Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
53
400mg chondroitin three times a day (TID) for twenty-four weeks
500mg glucosamine TID for twenty-four weeks
Columbia University
New York, New York, United States
Change in WOMAC Score
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.
Time frame: Baseline and 24 weeks
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