Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2021-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2015-08-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2015-08-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2021-11-12"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2021-11-16"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "no enough patients"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2021-10-01"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2021-11-12"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2021-11-16",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "The treatment schedule includes a daily dose of naltrexone for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Sugar Pill"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/type",
"value": "PLACEBO_COMPARATOR"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "The treatment schedule includes a daily dose of equivalent placebo for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames",
"value": [
"Drug: Sugar Pill"
]
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/armGroups/2"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
"value": "ReVia®"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Change in FACIT-fatigue Subscale Score From Randomization to End of Study"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al.\nCancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue).\nAccording to ICD10 criteria, a score <= 34 indicates significant cancer related fatigue.\nA change of 10 points has been shown to constitute a clinically meaningful difference on this subscale."
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/otherOutcomes"
},
{
"op": "add",
"path": "/protocolSection/ipdSharingStatementModule",
"value": {
"ipdSharing": "NO"
}
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "flmeyer@partners.org",
"title": "Fremonta Meyer, MD",
"organization": "Dana-Farber Cancer Institute/Brigham and Women's Hospital"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "Participants in the monitoring phase of the study will be followed for a maximum of 10 weeks, ending 4 weeks after cessation of radiotherapy or until they consent (if eligible) to participate in the intervention phase of the study, followed until the end of the study and beyond, until resolution or stabilization of the adverse event has occurred.",
"description": "Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher.\nAll remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events.\nMaximum grade toxicity by type was then calculated within SAE and OAE datasets.\nNo further data is available to specify classification of other beyond the general term.",
"eventGroups": [
{
"id": "EG000",
"title": "Naltrexone",
"description": "The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.",
"otherNumAtRisk": 2,
"deathsNumAtRisk": 2,
"otherNumAffected": 2,
"seriousNumAtRisk": 2,
"deathsNumAffected": 0,
"seriousNumAffected": 0
},
{
"id": "EG001",
"title": "Sugar Pill",
"description": "daily dose placebo for 5 week treatment period",
"otherNumAtRisk": 1,
"deathsNumAtRisk": 1,
"otherNumAffected": 1,
"seriousNumAtRisk": 1,
"deathsNumAffected": 0,
"seriousNumAffected": 0
}
],
"otherEvents": [
{
"term": "Dermatitis radiation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "irritability",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "mental fogginess",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 2,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Change in FACIT-fatigue Subscale Score From Randomization to End of Study",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Naltrexone",
"description": "<p>The treatment schedule includes a daily dose of naltrexone for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.</p><p>Naltrexone</p>"
},
{
"id": "OG001",
"title": "Sugar Pill",
"description": "<p>The treatment schedule includes a daily dose of equivalent placebo for 5 weeks.\nTreatment will be initiated at 25 mg/day during the first week to improve tolerability.\nThe dose will be escalated to 50 mg/day after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.</p><p>Sugar Pill</p>"
}
],
"timeFrame": "Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold",
"description": "Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al.\nCancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue).\nAccording to ICD10 criteria, a score <= 34 indicates significant cancer related fatigue.\nA change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.",
"reportingStatus": "POSTED",
"populationDescription": "trial terminated early"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Naltrexone",
"description": "The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
},
{
"id": "FG001",
"title": "Sugar Pill",
"description": "daily dose placebo for 5 week treatment period"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"comment": "Represents intervention phase",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
}
],
"dropWithdraws": [
{
"type": "trial terminated early",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
}
]
}
],
"preAssignmentDetails": "In the monitoring phase, eligibility for randomization was defined as FACIT-F subscale score >=10 pre-radiation therapy and decrease in FACIT-F of 10 points."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Naltrexone",
"description": "The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period."
},
{
"id": "BG001",
"title": "Placebo: Sugar Pill",
"description": "daily dose placebo for 5 week treatment period"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "49",
"groupId": "BG000",
"lowerLimit": "42",
"upperLimit": "56"
},
{
"value": "59",
"groupId": "BG001",
"lowerLimit": "59",
"upperLimit": "59"
},
{
"value": "52.3",
"groupId": "BG002",
"lowerLimit": "41",
"upperLimit": "59"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "Years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "White",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "3",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
]
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2016-03-30",
"size": 4890065,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2020-11-04T16:42",
"hasProtocol": true
},
{
"date": "2016-03-30",
"size": 4891365,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_001.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2020-11-04T16:46",
"hasProtocol": true
}
]
}
}
}
]