- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691678
Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
October 14, 2022 updated by: Dawn L. Hershman
Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients
Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Due to early detection and improved treatments, women with breast cancer are living longer.
The 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.
Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences.
However, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness.
Musculoskeletal 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.
Many 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.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age >21 years.
- Postmenopausal status defined as cessation of menses for >1 year or follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or bilateral oophorectomy.
- History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.
- Currently taking a third-generation aromatase inhibitor for at least 3 months.
- Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.
- 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.
- Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.
- If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients 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.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Hemoglobin A1c <8 within the last year.
- Signed informed consent.
Exclusion Criteria:
- Use of glucosamine or chondroitin within the past three (3) months.
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.
- 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).
- History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
- Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.
- 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.
- Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.
- Allergy to shellfish.
- Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
- Inability to understand the study procedures and/or give written informed consent.
- Alcohol use in excess of 3 mixed drinks/day.
- Corticosteroid treatment was used or administered.
- Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.
- Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.
- 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.
- Implementation of any other medical therapy for arthritis within one month prior to entry.
- Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.
- Participation in another clinical study with an investigational agent within the last 4 weeks.
- Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.
- Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.
Concurrent use of the following medications and dietary supplements.
- Chronic therapy with tetracycline or tetracycline derivatives.
- Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: chondroitin and glucosamine
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
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400mg chondroitin three times a day (TID) for twenty-four weeks
Other Names:
500mg glucosamine TID for twenty-four weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in WOMAC Score
Time Frame: Baseline and 24 weeks
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This is to demonstrate improvement in knee and/or joint pain and/or stiffness.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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Baseline and 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
October 14, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAC8748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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