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NCT02297412

Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel

Version 6 to 7 · Academic and Community Cancer Research United

Patch inspector

Version 6 to 7

137 operations 8 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_changedesign_info_changeeligibility_criteria_changephase_changeprimary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2016-01",
    "old_value": "2017-11",
    "delta_days": 670,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:44:38+00
Raw hash
47dc4748dd5a820031e4e68ef1a249cb6b1c0203379359a06cb2130537b29fe5
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 5 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 40
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Effectiveness of minocycline in paclitaxel-induced peripheral neuropathy as assessed by Quality of Life Questionnaires
After
Paclitaxel-induced acute pain syndrome as assessed by the Acute Pain Syndrome Symptom Summary Questionnaire
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 41
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Quality of Life Questionnaires will be used to determine the effectiveness of the minocycline.
After
Descriptive statistics and statistical plots will be mainly utilized.
Means and 95% CIs will be produced for continuous data for both the minocycline arm and the placebo arm.
For categorical/discrete data, frequency counts and percentage will be produced.
The mean estimates will be compared and differences in frequency distributions noted.
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 42
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
10 weeks
After
Up to course 12
add /protocolSection/outcomesModule/primaryOutcomes/1
Triage: Critical
Primary Outcome Change Operation 43
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
{
  "measure": "Paclitaxel-induced peripheral neuropathy as assessed by the European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 questionnaire and follow-up questionnaire",
  "timeFrame": "Up to course 12",
  "description": "Descriptive statistics and statistical plots will be mainly utilized.\nMeans and 95% confidence intervals (CIs) will be produced for continuous data for both the minocycline arm and the placebo arm.\nFor categorical/discrete data, frequency counts and percentage will be produced.\nThe mean estimates will be compared and differences in frequency distributions noted."
}
add /protocolSection/outcomesModule/primaryOutcomes/2
Triage: Critical
Primary Outcome Change Operation 44
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
{
  "measure": "Relative toxicities related to minocycline hydrochloride therapy as assessed by the change in the Acute Pain Syndrome Symptom Summary Questionnaire",
  "timeFrame": "Baseline to up to course 12",
  "description": "Descriptive statistics and statistical plots will be mainly utilized.\nMeans and 95% CIs will be produced for continuous data for both the minocycline arm and the placebo arm.\nFor categorical/discrete data, frequency counts and percentage will be produced.\nThe mean estimates will be compared and differences in frequency distributions noted."
}
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 25 ops
replace /protocolSection/designModule/phases/0
Triage: High
Design Change Operation 15
Matched rules
  • phase_change Trial phase changes are high review-priority design changes.
Before
EARLY_PHASE1
After
NA
replace /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 16
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
SINGLE_GROUP
After
PARALLEL
replace /protocolSection/designModule/designInfo/maskingInfo/masking
Triage: High
Design Change Operation 17
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
TRIPLE
After
DOUBLE
remove /protocolSection/designModule/designInfo/maskingInfo/whoMasked/1
Triage: High
Design Change Operation 18
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
CARE_PROVIDER
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Minocycline
After
Arm I (minocycline hydrochloride)
replace /protocolSection/armsInterventionsModule/armGroups/0/type
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
ACTIVE_COMPARATOR
After
EXPERIMENTAL
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Receive minocycline, by mouth starting on the day of chemotherapy and then twice daily while receiving paclitaxel chemotherapy.
After finishing paclitaxel the minocycline will continue for one week, and then stop.
After
Patients receive minocycline hydrochloride PO BID on days 1-7.
Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Minocycline
After
Drug: Minocycline Hydrochloride
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Quality-of-Life Assessment
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Questionnaire Administration
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 25
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Placebo
After
Arm II (placebo)
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 26
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Receive placebo (inactive agent), by mouth starting on the day of chemotherapy and then twice daily while receiving paclitaxel chemotherapy.
After finishing paclitaxel the placebo will continue for one week, and then stop.
After
Patients receive a placebo PO BID on days 1-7.
Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 27
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Placebo
After
Other: Placebo
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 28
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Quality-of-Life Assessment
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 29
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Questionnaire Administration
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 30
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Minocycline
After
Minocycline Hydrochloride
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 31
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Minocycline
After
Arm I (minocycline hydrochloride)
add /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 32
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Given PO
add /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 33
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "Dynacin",
  "Minocin",
  "Minomax",
  "Minomycin",
  "Tri-minocycline",
  "Vectrin"
]
replace /protocolSection/armsInterventionsModule/interventions/1/type
Triage: High
Arm Intervention Change Operation 34
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
DRUG
After
OTHER
replace /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 35
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Placebo
After
Arm II (placebo)
add /protocolSection/armsInterventionsModule/interventions/1/description
Triage: High
Arm Intervention Change Operation 36
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Given PO
add /protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
Arm Intervention Change Operation 37
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "placebo therapy",
  "PLCB",
  "sham therapy"
]
add /protocolSection/armsInterventionsModule/interventions/2
Triage: High
Arm Intervention Change Operation 38
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Quality-of-Life Assessment",
  "type": "OTHER",
  "otherNames": [
    "Quality of Life Assessment"
  ],
  "description": "Ancillary studies",
  "armGroupLabels": [
    "Arm I (minocycline hydrochloride)",
    "Arm II (placebo)"
  ]
}
add /protocolSection/armsInterventionsModule/interventions/3
Triage: High
Arm Intervention Change Operation 39
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Questionnaire Administration",
  "type": "OTHER",
  "description": "Ancillary studies",
  "armGroupLabels": [
    "Arm I (minocycline hydrochloride)",
    "Arm II (placebo)"
  ]
}
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 45
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Ability to complete questionnaires by themselves or with assistance</li><li>Planned paclitaxel at a dose of 80 mg&#x2F;m2 I.V. given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and&#x2F;or other antibody and&#x2F;or small molecule treatment is allowed, except for PARP inhibitors).</li><li>Life expectancy &gt;6 months</li><li>ECOG performance status 0 or 1. (Form is available on the ACCRU web site https:&#x2F;&#x2F;www.accru.org&#x2F;accru&#x2F;forms&#x2F;NonProtocolSpecificForms&#x2F;index.html)</li><li>Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion).</li></ul><p>Exclusion Criteria:</p><ul><li>Any of the following:</li><li>Pregnant women</li><li>Nursing women</li><li>Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects</li><li>Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause.</li><li>History of allergic or other adverse reactions to minocycline</li><li>Prior exposure to neurotoxic chemotherapy.</li><li>Diagnosis of fibromyalgia.</li><li>Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Ability to complete questionnaires by themselves or with assistance</li><li>Planned paclitaxel at a dose of 80 mg&#x2F;m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and&#x2F;or other antibody and&#x2F;or small molecule treatment is allowed, except for PARP inhibitors)</li><li>Life expectancy &gt; 6 months</li><li>Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1</li><li>Negative pregnancy test (serum or urine) done =&lt; 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)</li></ul><p>Exclusion Criteria:</p><ul><li><p>Any of the following:</p><ul><li>Pregnant women</li><li>Nursing women</li><li>Men or women of childbearing potential who are unwilling to employ adequate contraception</li></ul></li><li>Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause</li><li>History of allergic or other adverse reactions to minocycline</li><li>Prior exposure to neurotoxic chemotherapy</li><li>Diagnosis of fibromyalgia</li><li>Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids</li><li>History of allergic or other adverse reactions to tetracycline</li></ul>
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2017-11
After
2016-01
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 91 ops
replace /protocolSection/contactsLocationsModule/overallOfficials/0/name
Triage: Uncategorized
Uncategorized Operation 46
Before
Charles Loprinzi, M.D.
After
Charles Loprinzi
replace /protocolSection/contactsLocationsModule/overallOfficials/0/affiliation
Triage: Uncategorized
Uncategorized Operation 47
Before
Mayo Clinic
After
Academic and Community Cancer Research United
replace /protocolSection/contactsLocationsModule/overallOfficials/0/role
Triage: Uncategorized
Uncategorized Operation 48
Before
STUDY_CHAIR
After
PRINCIPAL_INVESTIGATOR
replace /protocolSection/contactsLocationsModule/locations/0/facility
Triage: Uncategorized
Uncategorized Operation 49
Before
Palchak David MD
After
PCR Oncology
add /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 50
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 51
After
[
  {
    "name": "David L. Palchak",
    "role": "CONTACT",
    "email": "dpalchak@pcroncology.com",
    "phone": "805-474-9143"
  },
  {
    "name": "David L. Palchak",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/1/facility
Triage: Uncategorized
Uncategorized Operation 52
Before
Illinois Cancer Care, PC
After
Illinois CancerCare-Community Cancer Center
replace /protocolSection/contactsLocationsModule/locations/1/city
Triage: Uncategorized
Uncategorized Operation 53
Before
Peoria
After
Normal
replace /protocolSection/contactsLocationsModule/locations/1/zip
Triage: Uncategorized
Uncategorized Operation 54
Before
61615
After
61761
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 55
Before
40.69365
After
40.5142
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 56
Before
-89.58899
After
-88.99063
add /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 57
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 58
After
[
  {
    "name": "Madhuri Bajaj",
    "role": "CONTACT",
    "email": "mbajaj@illinoiscancecare.com",
    "phone": "309-243-3000"
  },
  {
    "name": "Madhuri Bajaj",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
add /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 59
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/2/contacts
Triage: Uncategorized
Uncategorized Operation 60
After
[
  {
    "name": "Vamsi K. Vasireddy",
    "role": "CONTACT",
    "email": "Vamsi.Vasireddy@Carle.com",
    "phone": "800-446-5532"
  },
  {
    "name": "Vamsi K. Vasireddy",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/3/facility
Triage: Uncategorized
Uncategorized Operation 61
Before
Iowa Oncology Research Association CCOP
After
Siouxland Regional Cancer Center
replace /protocolSection/contactsLocationsModule/locations/3/city
Triage: Uncategorized
Uncategorized Operation 62
Before
Des Moines
After
Sioux City
replace /protocolSection/contactsLocationsModule/locations/3/zip
Triage: Uncategorized
Uncategorized Operation 63
Before
50309
After
51101
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 64
Before
41.60054
After
42.49999
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 65
Before
-93.60911
After
-96.40031
add /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 66
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/3/contacts
Triage: Uncategorized
Uncategorized Operation 67
After
[
  {
    "name": "Donald B. Wender",
    "role": "CONTACT",
    "email": "drednew@msn.com",
    "phone": "712-252-0088"
  },
  {
    "name": "Donald B. Wender",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/4/facility
Triage: Uncategorized
Uncategorized Operation 68
Before
Siouxland Hematology - Oncology Associates, LLP
After
Michigan Cancer Research Consortium NCORP
replace /protocolSection/contactsLocationsModule/locations/4/city
Triage: Uncategorized
Uncategorized Operation 69
Before
Sioux City
After
Ann Arbor
replace /protocolSection/contactsLocationsModule/locations/4/state
Triage: Uncategorized
Uncategorized Operation 70
Before
Iowa
After
Michigan
replace /protocolSection/contactsLocationsModule/locations/4/zip
Triage: Uncategorized
Uncategorized Operation 71
Before
51101
After
48106
replace /protocolSection/contactsLocationsModule/locations/4/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 72
Before
42.49999
After
42.27756
replace /protocolSection/contactsLocationsModule/locations/4/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 73
Before
-96.40031
After
-83.74088
add /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 74
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/5/facility
Triage: Uncategorized
Uncategorized Operation 75
Before
Michigan Cancer Research Consortium Community Clinical Oncology Program
After
Mayo Clinic
replace /protocolSection/contactsLocationsModule/locations/5/city
Triage: Uncategorized
Uncategorized Operation 76
Before
Ann Arbor
After
Rochester
replace /protocolSection/contactsLocationsModule/locations/5/state
Triage: Uncategorized
Uncategorized Operation 77
Before
Michigan
After
Minnesota
replace /protocolSection/contactsLocationsModule/locations/5/zip
Triage: Uncategorized
Uncategorized Operation 78
Before
48106
After
55905
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 79
Before
42.27756
After
44.02163
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 80
Before
-83.74088
After
-92.4699
add /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 81
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/5/contacts
Triage: Uncategorized
Uncategorized Operation 82
After
[
  {
    "name": "Charles L. Loprinzi",
    "role": "CONTACT",
    "email": "Loprinzi.charles@mayo.edu",
    "phone": "507-284-2511"
  },
  {
    "name": "Charles L. Loprinzi",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/6/facility
Triage: Uncategorized
Uncategorized Operation 83
Before
Mayo Clinic
After
Coborn Cancer Center at Saint Cloud Hospital
replace /protocolSection/contactsLocationsModule/locations/6/city
Triage: Uncategorized
Uncategorized Operation 84
Before
Rochester
After
Saint Cloud
replace /protocolSection/contactsLocationsModule/locations/6/zip
Triage: Uncategorized
Uncategorized Operation 85
Before
55905
After
56303
replace /protocolSection/contactsLocationsModule/locations/6/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 86
Before
44.02163
After
45.5608
replace /protocolSection/contactsLocationsModule/locations/6/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 87
Before
-92.4699
After
-94.16249
add /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 88
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/6/contacts
Triage: Uncategorized
Uncategorized Operation 89
After
[
  {
    "name": "Donald J. Jurgens",
    "role": "CONTACT",
    "email": "jurgensd@centracare.com",
    "phone": "320-229-4907"
  },
  {
    "name": "Donald J. Jurgens",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/7/facility
Triage: Uncategorized
Uncategorized Operation 90
Before
Coborn Cancer Center &#x2F; CentraCare Clinic
After
Missouri Valley Cancer Consortium
replace /protocolSection/contactsLocationsModule/locations/7/city
Triage: Uncategorized
Uncategorized Operation 91
Before
Saint Cloud
After
Omaha
replace /protocolSection/contactsLocationsModule/locations/7/state
Triage: Uncategorized
Uncategorized Operation 92
Before
Minnesota
After
Nebraska
replace /protocolSection/contactsLocationsModule/locations/7/zip
Triage: Uncategorized
Uncategorized Operation 93
Before
56303
After
68106
replace /protocolSection/contactsLocationsModule/locations/7/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 94
Before
45.5608
After
41.25626
replace /protocolSection/contactsLocationsModule/locations/7/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 95
Before
-94.16249
After
-95.94043
add /protocolSection/contactsLocationsModule/locations/7/status
Triage: Uncategorized
Uncategorized Operation 96
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/7/contacts
Triage: Uncategorized
Uncategorized Operation 97
After
[
  {
    "name": "Gamini S. Soori",
    "role": "CONTACT",
    "email": "gsoori@mvcc.cc",
    "phone": "402-991-8070"
  },
  {
    "name": "Gamini S. Soori",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/8/facility
Triage: Uncategorized
Uncategorized Operation 98
Before
Metro-Minnesota Community Clinical Oncology Program (CCOP)
After
Hematology Oncology Associates of Central New York-East Syracuse
replace /protocolSection/contactsLocationsModule/locations/8/city
Triage: Uncategorized
Uncategorized Operation 99
Before
Saint Louis Park
After
East Syracuse
replace /protocolSection/contactsLocationsModule/locations/8/state
Triage: Uncategorized
Uncategorized Operation 100
Before
Minnesota
After
New York
replace /protocolSection/contactsLocationsModule/locations/8/zip
Triage: Uncategorized
Uncategorized Operation 101
Before
55426
After
13057
replace /protocolSection/contactsLocationsModule/locations/8/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 102
Before
44.9483
After
43.06534
replace /protocolSection/contactsLocationsModule/locations/8/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 103
Before
-93.34801
After
-76.07853
add /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 104
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/8/contacts
Triage: Uncategorized
Uncategorized Operation 105
After
[
  {
    "name": "Jeffrey J. Kirshner",
    "role": "CONTACT",
    "email": "jkirshner@hoacny.com",
    "phone": "315-472-7504",
    "phoneExt": "1350"
  },
  {
    "name": "Jeffrey J. Kirshner",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/9/facility
Triage: Uncategorized
Uncategorized Operation 106
Before
Missouri Valley Cancer Consortium
After
Novant Health Oncology Specialists
replace /protocolSection/contactsLocationsModule/locations/9/city
Triage: Uncategorized
Uncategorized Operation 107
Before
Omaha
After
Winston-Salem
replace /protocolSection/contactsLocationsModule/locations/9/state
Triage: Uncategorized
Uncategorized Operation 108
Before
Nebraska
After
North Carolina
replace /protocolSection/contactsLocationsModule/locations/9/zip
Triage: Uncategorized
Uncategorized Operation 109
Before
68106
After
27103
replace /protocolSection/contactsLocationsModule/locations/9/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 110
Before
41.25626
After
36.09986
replace /protocolSection/contactsLocationsModule/locations/9/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 111
Before
-95.94043
After
-80.24422
add /protocolSection/contactsLocationsModule/locations/9/status
Triage: Uncategorized
Uncategorized Operation 112
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/9/contacts
Triage: Uncategorized
Uncategorized Operation 113
After
[
  {
    "name": "Judith O. Hopkins",
    "role": "CONTACT",
    "email": "johopkins@novanthealth.org",
    "phone": "336-277-8800"
  },
  {
    "name": "Judith O. Hopkins",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/10/facility
Triage: Uncategorized
Uncategorized Operation 114
Before
Hematology Oncology Associates of Central New York PC
After
Women and Infants Hospital
replace /protocolSection/contactsLocationsModule/locations/10/city
Triage: Uncategorized
Uncategorized Operation 115
Before
East Syracuse
After
Providence
replace /protocolSection/contactsLocationsModule/locations/10/state
Triage: Uncategorized
Uncategorized Operation 116
Before
New York
After
Rhode Island
replace /protocolSection/contactsLocationsModule/locations/10/zip
Triage: Uncategorized
Uncategorized Operation 117
Before
13057
After
02905
replace /protocolSection/contactsLocationsModule/locations/10/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 118
Before
43.06534
After
41.82399
replace /protocolSection/contactsLocationsModule/locations/10/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 119
Before
-76.07853
After
-71.41283
add /protocolSection/contactsLocationsModule/locations/10/status
Triage: Uncategorized
Uncategorized Operation 120
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/10/contacts
Triage: Uncategorized
Uncategorized Operation 121
After
[
  {
    "name": "Bachir J. Sakr",
    "role": "CONTACT",
    "email": "bsakr@wihri.org",
    "phone": "401-453-7520"
  },
  {
    "name": "Bachir J. Sakr",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
replace /protocolSection/contactsLocationsModule/locations/11/facility
Triage: Uncategorized
Uncategorized Operation 122
Before
Novant Health Presbyterian Medical Center - SECCC
After
Marshfield Clinic
replace /protocolSection/contactsLocationsModule/locations/11/city
Triage: Uncategorized
Uncategorized Operation 123
Before
Charlotte
After
Marshfield
replace /protocolSection/contactsLocationsModule/locations/11/state
Triage: Uncategorized
Uncategorized Operation 124
Before
North Carolina
After
Wisconsin
replace /protocolSection/contactsLocationsModule/locations/11/zip
Triage: Uncategorized
Uncategorized Operation 125
Before
28204
After
54449
replace /protocolSection/contactsLocationsModule/locations/11/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 126
Before
35.22709
After
44.66885
replace /protocolSection/contactsLocationsModule/locations/11/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 127
Before
-80.84313
After
-90.1718
add /protocolSection/contactsLocationsModule/locations/11/status
Triage: Uncategorized
Uncategorized Operation 128
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/11/contacts
Triage: Uncategorized
Uncategorized Operation 129
After
[
  {
    "name": "Adedayo A. Onitilo",
    "role": "CONTACT",
    "email": "Onitilo.adedayo@marshfieldclinic.org",
    "phone": "800-782-8581",
    "phoneExt": "75416"
  },
  {
    "name": "Adedayo A. Onitilo",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 130
Before
{
  "zip": "27710",
  "city": "Durham",
  "state": "North Carolina",
  "country": "United States",
  "facility": "Duke University Medical Center",
  "geoPoint": {
    "lat": 35.99403,
    "lon": -78.89862
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 131
Before
{
  "zip": "28791",
  "city": "Hendersonville",
  "state": "North Carolina",
  "country": "United States",
  "facility": "Margaret R. Pardee Mem. Hospital - SECCC",
  "geoPoint": {
    "lat": 35.31873,
    "lon": -82.46095
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 132
Before
{
  "zip": "27103",
  "city": "Winston-Salem",
  "state": "North Carolina",
  "country": "United States",
  "facility": "Novant Health Forsyth Medical Center - SECCC",
  "geoPoint": {
    "lat": 36.09986,
    "lon": -80.24422
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 133
Before
{
  "zip": "58201",
  "city": "Grand Forks",
  "state": "North Dakota",
  "country": "United States",
  "facility": "Altru Cancer Center",
  "geoPoint": {
    "lat": 47.92526,
    "lon": -97.03285
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 134
Before
{
  "zip": "02905",
  "city": "Providence",
  "state": "Rhode Island",
  "country": "United States",
  "facility": "Women and Infants Hospital",
  "geoPoint": {
    "lat": 41.82399,
    "lon": -71.41283
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 135
Before
{
  "zip": "29621",
  "city": "Anderson",
  "state": "South Carolina",
  "country": "United States",
  "facility": "AnMed Health - SECCC",
  "geoPoint": {
    "lat": 34.50344,
    "lon": -82.65013
  }
}
remove /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 136
Before
{
  "zip": "54449",
  "city": "Marshfield",
  "state": "Wisconsin",
  "country": "United States",
  "facility": "Marshfield Clinic - Marshfield Center",
  "geoPoint": {
    "lat": 44.66885,
    "lon": -90.1718
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 8 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2016-07
After
2016-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2016-07-11
After
2016-12-30
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2016-07-12
After
2017-01-04
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 10
Before
The purpose of this study is to compare the effects, good and&#x2F;or bad, of minocycline with placebo (an inactive agent) on symptoms caused by paclitaxel.
In this study, the participant will get the minocycline or a placebo starting on the morning of the first dose of chemotherapy and continuing twice a day until a week after chemotherapy is finished.
After
This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel.
Drugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes.
Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients.
add /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 11
After
<p>PRIMARY OBJECTIVES:</p><p>I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.</p><p>II.
To estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).</p><p>III.
To examine the possible relative toxicities related to minocycline therapy in this study situation.</p><p>OUTLINE: Patients are randomized to 1 of 2 arms.</p><p>ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7.
Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive a placebo PO BID on days 1-7.
Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of the study, patients are followed up every month for 6 months.</p>
replace /protocolSection/conditionsModule/conditions/0
Triage: Uncategorized
Uncategorized Operation 12
Before
Breast Cancer
After
Acute Pain
add /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 13
After
Breast Carcinoma
add /protocolSection/conditionsModule/conditions/2
Triage: Uncategorized
Uncategorized Operation 14
After
Peripheral Neuropathy
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 4 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Pilot Clinical Trial Evaluating the Utility of Minocycline as an Agent to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Placebo-Controlled, Double Blind Trial
After
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
add /protocolSection/identificationModule/secondaryIdInfos
Triage: Uncategorized
Uncategorized Operation 2
After
[
  {
    "id": "NCI-2016-01592",
    "type": "REGISTRY",
    "domain": "CTRP (Clinical Trial Reporting Program)"
  },
  {
    "id": "RU221408I",
    "type": "OTHER",
    "domain": "Academic and Community Cancer Research United"
  },
  {
    "id": "P30CA015083",
    "link": "https:&#x2F;&#x2F;reporter.nih.gov&#x2F;quickSearch&#x2F;P30CA015083",
    "type": "NIH"
  }
]
add /protocolSection/sponsorCollaboratorsModule/collaborators
Triage: Uncategorized
Uncategorized Operation 9
After
[
  {
    "name": "National Cancer Institute (NCI)",
    "class": "NIH"
  }
]
add /protocolSection/oversightModule
Triage: Uncategorized
Uncategorized Operation 137
After
{
  "oversightHasDmc": true
}
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 4
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos",
    "value": [
      {
        "id": "NCI-2016-01592",
        "type": "REGISTRY",
        "domain": "CTRP (Clinical Trial Reporting Program)"
      },
      {
        "id": "RU221408I",
        "type": "OTHER",
        "domain": "Academic and Community Cancer Research United"
      },
      {
        "id": "P30CA015083",
        "link": "https:&#x2F;&#x2F;reporter.nih.gov&#x2F;quickSearch&#x2F;P30CA015083",
        "type": "NIH"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2016-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2016-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2016-12-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2017-01-04"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/collaborators",
    "value": [
      {
        "name": "National Cancer Institute (NCI)",
        "class": "NIH"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This randomized pilot trial studies how well minocycline hydrochloride works in reducing chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer undergoing treatment with paclitaxel.\nDrugs used in chemotherapy, such as paclitaxel, may cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and toes.\nMinocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the quality of life in breast cancer patients."
  },
  {
    "op": "add",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>PRIMARY OBJECTIVES:</p><p>I. To estimate whether minocycline hydrochloride (minocycline) can alleviate paclitaxel-induced peripheral neuropathy.</p><p>II.\nTo estimate whether minocycline can alleviate paclitaxel acute pain syndrome (P-APS).</p><p>III.\nTo examine the possible relative toxicities related to minocycline therapy in this study situation.</p><p>OUTLINE: Patients are randomized to 1 of 2 arms.</p><p>ARM I: Patients receive minocycline hydrochloride orally (PO) twice daily (BID) on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.</p><p>ARM II: Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.</p><p>After completion of the study, patients are followed up every month for 6 months.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "Acute Pain"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/1",
    "value": "Breast Carcinoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/2",
    "value": "Peripheral Neuropathy"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/phases/0",
    "value": "NA"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/maskingInfo/masking",
    "value": "DOUBLE"
  },
  {
    "op": "remove",
    "path": "/protocolSection/designModule/designInfo/maskingInfo/whoMasked/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Arm I (minocycline hydrochloride)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/type",
    "value": "EXPERIMENTAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Patients receive minocycline hydrochloride PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: Minocycline Hydrochloride"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
    "value": "Other: Questionnaire Administration"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Arm II (placebo)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "Patients receive a placebo PO BID on days 1-7.\nTreatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Other: Placebo"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
    "value": "Other: Questionnaire Administration"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Minocycline Hydrochloride"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Arm I (minocycline hydrochloride)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Given PO"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "value": [
      "Dynacin",
      "Minocin",
      "Minomax",
      "Minomycin",
      "Tri-minocycline",
      "Vectrin"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/type",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
    "value": "Arm II (placebo)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/description",
    "value": "Given PO"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames",
    "value": [
      "placebo therapy",
      "PLCB",
      "sham therapy"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2",
    "value": {
      "name": "Quality-of-Life Assessment",
      "type": "OTHER",
      "otherNames": [
        "Quality of Life Assessment"
      ],
      "description": "Ancillary studies",
      "armGroupLabels": [
        "Arm I (minocycline hydrochloride)",
        "Arm II (placebo)"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/3",
    "value": {
      "name": "Questionnaire Administration",
      "type": "OTHER",
      "description": "Ancillary studies",
      "armGroupLabels": [
        "Arm I (minocycline hydrochloride)",
        "Arm II (placebo)"
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Paclitaxel-induced acute pain syndrome as assessed by the Acute Pain Syndrome Symptom Summary Questionnaire"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Descriptive statistics and statistical plots will be mainly utilized.\nMeans and 95% CIs will be produced for continuous data for both the minocycline arm and the placebo arm.\nFor categorical&#x2F;discrete data, frequency counts and percentage will be produced.\nThe mean estimates will be compared and differences in frequency distributions noted."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to course 12"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1",
    "value": {
      "measure": "Paclitaxel-induced peripheral neuropathy as assessed by the European Organization for Research and Treatment of Cancer Chemotherapy-Induced Peripheral Neuropathy 20 questionnaire and follow-up questionnaire",
      "timeFrame": "Up to course 12",
      "description": "Descriptive statistics and statistical plots will be mainly utilized.\nMeans and 95% confidence intervals (CIs) will be produced for continuous data for both the minocycline arm and the placebo arm.\nFor categorical&#x2F;discrete data, frequency counts and percentage will be produced.\nThe mean estimates will be compared and differences in frequency distributions noted."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/2",
    "value": {
      "measure": "Relative toxicities related to minocycline hydrochloride therapy as assessed by the change in the Acute Pain Syndrome Symptom Summary Questionnaire",
      "timeFrame": "Baseline to up to course 12",
      "description": "Descriptive statistics and statistical plots will be mainly utilized.\nMeans and 95% CIs will be produced for continuous data for both the minocycline arm and the placebo arm.\nFor categorical&#x2F;discrete data, frequency counts and percentage will be produced.\nThe mean estimates will be compared and differences in frequency distributions noted."
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Ability to complete questionnaires by themselves or with assistance</li><li>Planned paclitaxel at a dose of 80 mg&#x2F;m2 IV given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and&#x2F;or other antibody and&#x2F;or small molecule treatment is allowed, except for PARP inhibitors)</li><li>Life expectancy &gt; 6 months</li><li>Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1</li><li>Negative pregnancy test (serum or urine) done =&lt; 7 days prior to registration, for women of childbearing potential only (determined per clinician discretion)</li></ul><p>Exclusion Criteria:</p><ul><li><p>Any of the following:</p><ul><li>Pregnant women</li><li>Nursing women</li><li>Men or women of childbearing potential who are unwilling to employ adequate contraception</li></ul></li><li>Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause</li><li>History of allergic or other adverse reactions to minocycline</li><li>Prior exposure to neurotoxic chemotherapy</li><li>Diagnosis of fibromyalgia</li><li>Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids</li><li>History of allergic or other adverse reactions to tetracycline</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/name",
    "value": "Charles Loprinzi"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/affiliation",
    "value": "Academic and Community Cancer Research United"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials/0/role",
    "value": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
    "value": "PCR Oncology"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts",
    "value": [
      {
        "name": "David L. Palchak",
        "role": "CONTACT",
        "email": "dpalchak@pcroncology.com",
        "phone": "805-474-9143"
      },
      {
        "name": "David L. Palchak",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/facility",
    "value": "Illinois CancerCare-Community Cancer Center"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/city",
    "value": "Normal"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/zip",
    "value": "61761"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/geoPoint/lat",
    "value": 40.5142
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/geoPoint/lon",
    "value": -88.99063
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/contacts",
    "value": [
      {
        "name": "Madhuri Bajaj",
        "role": "CONTACT",
        "email": "mbajaj@illinoiscancecare.com",
        "phone": "309-243-3000"
      },
      {
        "name": "Madhuri Bajaj",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/2/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/2/contacts",
    "value": [
      {
        "name": "Vamsi K. Vasireddy",
        "role": "CONTACT",
        "email": "Vamsi.Vasireddy@Carle.com",
        "phone": "800-446-5532"
      },
      {
        "name": "Vamsi K. Vasireddy",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/facility",
    "value": "Siouxland Regional Cancer Center"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/city",
    "value": "Sioux City"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/zip",
    "value": "51101"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lat",
    "value": 42.49999
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lon",
    "value": -96.40031
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/3/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/3/contacts",
    "value": [
      {
        "name": "Donald B. Wender",
        "role": "CONTACT",
        "email": "drednew@msn.com",
        "phone": "712-252-0088"
      },
      {
        "name": "Donald B. Wender",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/facility",
    "value": "Michigan Cancer Research Consortium NCORP"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/city",
    "value": "Ann Arbor"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/state",
    "value": "Michigan"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/zip",
    "value": "48106"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/geoPoint/lat",
    "value": 42.27756
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/geoPoint/lon",
    "value": -83.74088
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/4/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/facility",
    "value": "Mayo Clinic"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/city",
    "value": "Rochester"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/state",
    "value": "Minnesota"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/zip",
    "value": "55905"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lat",
    "value": 44.02163
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lon",
    "value": -92.4699
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/5/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/5/contacts",
    "value": [
      {
        "name": "Charles L. Loprinzi",
        "role": "CONTACT",
        "email": "Loprinzi.charles@mayo.edu",
        "phone": "507-284-2511"
      },
      {
        "name": "Charles L. Loprinzi",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/facility",
    "value": "Coborn Cancer Center at Saint Cloud Hospital"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/city",
    "value": "Saint Cloud"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/zip",
    "value": "56303"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/geoPoint/lat",
    "value": 45.5608
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/geoPoint/lon",
    "value": -94.16249
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/6/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/6/contacts",
    "value": [
      {
        "name": "Donald J. Jurgens",
        "role": "CONTACT",
        "email": "jurgensd@centracare.com",
        "phone": "320-229-4907"
      },
      {
        "name": "Donald J. Jurgens",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/facility",
    "value": "Missouri Valley Cancer Consortium"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/city",
    "value": "Omaha"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/state",
    "value": "Nebraska"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/zip",
    "value": "68106"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/geoPoint/lat",
    "value": 41.25626
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/7/geoPoint/lon",
    "value": -95.94043
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7/contacts",
    "value": [
      {
        "name": "Gamini S. Soori",
        "role": "CONTACT",
        "email": "gsoori@mvcc.cc",
        "phone": "402-991-8070"
      },
      {
        "name": "Gamini S. Soori",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/facility",
    "value": "Hematology Oncology Associates of Central New York-East Syracuse"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/city",
    "value": "East Syracuse"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/state",
    "value": "New York"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/zip",
    "value": "13057"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/geoPoint/lat",
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  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/geoPoint/lon",
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  {
    "op": "add",
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    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/8/contacts",
    "value": [
      {
        "name": "Jeffrey J. Kirshner",
        "role": "CONTACT",
        "email": "jkirshner@hoacny.com",
        "phone": "315-472-7504",
        "phoneExt": "1350"
      },
      {
        "name": "Jeffrey J. Kirshner",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/facility",
    "value": "Novant Health Oncology Specialists"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/city",
    "value": "Winston-Salem"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/state",
    "value": "North Carolina"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/zip",
    "value": "27103"
  },
  {
    "op": "replace",
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  {
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  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/9/contacts",
    "value": [
      {
        "name": "Judith O. Hopkins",
        "role": "CONTACT",
        "email": "johopkins@novanthealth.org",
        "phone": "336-277-8800"
      },
      {
        "name": "Judith O. Hopkins",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/facility",
    "value": "Women and Infants Hospital"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/city",
    "value": "Providence"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/state",
    "value": "Rhode Island"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/zip",
    "value": "02905"
  },
  {
    "op": "replace",
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    "value": 41.82399
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/geoPoint/lon",
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  },
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  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/10/contacts",
    "value": [
      {
        "name": "Bachir J. Sakr",
        "role": "CONTACT",
        "email": "bsakr@wihri.org",
        "phone": "401-453-7520"
      },
      {
        "name": "Bachir J. Sakr",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/facility",
    "value": "Marshfield Clinic"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/city",
    "value": "Marshfield"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/state",
    "value": "Wisconsin"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/zip",
    "value": "54449"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/geoPoint/lat",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/11/geoPoint/lon",
    "value": -90.1718
  },
  {
    "op": "add",
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  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/11/contacts",
    "value": [
      {
        "name": "Adedayo A. Onitilo",
        "role": "CONTACT",
        "email": "Onitilo.adedayo@marshfieldclinic.org",
        "phone": "800-782-8581",
        "phoneExt": "75416"
      },
      {
        "name": "Adedayo A. Onitilo",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/12"
  },
  {
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    "path": "/protocolSection/contactsLocationsModule/locations/12"
  },
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  },
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  },
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  },
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    "path": "/protocolSection/contactsLocationsModule/locations/12"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/12"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule",
    "value": {
      "oversightHasDmc": true
    }
  }
]