Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2017-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/startDateStruct/date",
"value": "2008-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2012-09"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2017-06-15"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2017-06-19"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors."
},
{
"op": "add",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "Due to early detection and improved treatments, women with breast cancer are living longer.\nThe increase in breast cancer survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer.\nRecent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences.\nHowever, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness.\nMusculoskeletal pain, which occurs in up to 50% of patients treated with AIs, often does not respond to conventional pain medications, may lead to noncompliance, may cause major disability, and may interfere with quality of life.\nMany women are unable to tolerate these life-saving drugs because of severe joint pain, therefore, safe and effective treatments that alleviate these symptoms are needed."
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/1",
"value": "Joint Pain"
},
{
"op": "replace",
"path": "/protocolSection/designModule/designInfo/allocation",
"value": "NA"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "chondroitin and glucosamine"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Drug: Chondroitin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
"value": "Drug: Glucosamine"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "Chondroitin"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "400mg chondroitin TID for twenty-four weeks"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "chondroitin and glucosamine"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"value": [
"Chondroitin sulfate"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/1",
"value": {
"name": "Glucosamine",
"type": "DRUG",
"otherNames": [
"Glucosamine sulfate"
],
"description": "500mg glucosamine TID for twenty-four weeks",
"armGroupLabels": [
"chondroitin and glucosamine"
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Prevalence of reduced knee and/or joint pain and/or stiffness"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria, which provides a combined assessment of changes in pain, function, and the patient's global assessment of disease status."
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Age >21 years.</li><li>Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL or bilateral oophorectomy.</li><li>History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.</li><li>Currently taking a third-generation aromatase inhibitor for at least 3 months.</li><li>Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.</li><li>Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.</li><li>Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.</li><li>If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose.\nPatients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.</li><li>ECOG performance status 0-2.</li><li>Hemoglobin A1c <8 within the last year.</li><li>Signed informed consent.</li></ul><p>Exclusion Criteria:</p><ul><li>Use of glucosamine or chondroitin within the past three (3) months.</li><li>Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.</li><li>History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).</li><li>History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.</li><li>Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.</li><li>History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.</li><li>Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.</li><li>Allergy to shellfish.</li><li>Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.</li><li>Inability to understand the study procedures and/or give written informed consent.</li><li>Alcohol use in excess of 3 mixed drinks/day.</li><li>Corticosteroid treatment was used or administered.</li><li>Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.</li><li>Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.</li><li>Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.</li><li>Implementation of any other medical therapy for arthritis within one month prior to entry.</li><li>Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month.\nIn addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.</li><li>Participation in another clinical study with an investigational agent within the last 4 weeks.</li><li>Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.</li><li>Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.</li><li><p>Concurrent use of the following medications and dietary supplements.</p><ul><li>Chronic therapy with tetracycline or tetracycline derivatives.</li><li>Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.</li></ul></li></ul>"
},
{
"op": "add",
"path": "/protocolSection/ipdSharingStatementModule",
"value": {
"ipdSharing": "UNDECIDED"
}
},
{
"op": "add",
"path": "/annotationSection",
"value": {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2021-07-13",
"type": "RELEASE"
},
{
"date": "2021-08-03",
"type": "RESET"
}
],
"unpostedResponsibleParty": "Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University"
}
}
}
}
]