| June 3, 2008 |
| February 2, 2009 |
| May 2008 |
| January 2011 (final data collection date for primary outcome measure) |
| Change in Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria (composite endpoint including pain, function, and the patient's global assessment of disease) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00691678 on ClinicalTrials.gov Archive Site |
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| Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer |
| 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 |
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| Phase II |
| Interventional |
| Supportive Care, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Breast Cancer |
| Dietary Supplement: Glucosamine Chondroitin |
| Experimental: Glucosamine Chondroitin |
| |
| |
| Recruiting |
| 53 |
| January 2011 |
| January 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age >21 years
- Postmenopausal status defined as cessation of menses for >1 year or FSH >20 mIU/mL
- History of stage I, II or IIIA 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.
- ECOG performance status 0-2.
- Hemoglobin A1c <8.
- Signed informed consent
Exclusion Criteria:
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| Female |
| 21 Years and older |
| No |
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| United States |
| |
| NCT00691678 |
| Dawn Hershman, Columbia University |
| IRB-AAAC8748 |
| Columbia University |
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| Principal Investigator: |
Dawn Hershman, MD |
Columbia University |
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| Columbia University |
| February 2009 |