Abstract | PURPOSE: METHODS: We conducted a single-arm, open-label, phase II study evaluating glucosamine-sulfate (1,500 mg/day) + chondroitin- sulfate (1,200 mg/day) for 24 weeks to treat joint pain/stiffness in postmenopausal women with early stage breast cancer who developed moderate-to-severe joint pain after initiating AIs. The primary endpoint was improvement in pain/stiffness at week 24 assessed by the Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria. Secondary endpoints assessed changes in pain, stiffness, and function using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index for hips/knees and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) for hands/wrists. The Brief Pain Inventory (BPI) assessed pain interference, severity, and worst pain. RESULTS: Of 53 patients enrolled, 39 were evaluable at week 24. From baseline to week 24, 46 % of patients improved according to OMERACT-OARSI criteria. At week 24, there were improvements (all P < 0.05) in pain and function as assessed by WOMAC and M-SACRAH, and in pain interference, severity, and worst pain as assessed by BPI. Estradiol levels did not change from baseline. The most commonly reported side effects were headache (28 %), dyspepsia (15 %), and nausea (17 %). CONCLUSIONS: In this single-arm study, 24 weeks of glucosamine/ chondroitin resulted in moderate improvements in AI-induced arthralgias, with minimal side effects, and no changes in estradiol levels. These results suggest a need to evaluate efficacy in a placebo-controlled trial.
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Authors | Heather Greenlee, Katherine D Crew, Theresa Shao, Grace Kranwinkel, Kevin Kalinsky, Matthew Maurer, Lois Brafman, Beverly Insel, Wei Yann Tsai, Dawn L Hershman |
Journal | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
(Support Care Cancer)
Vol. 21
Issue 4
Pg. 1077-87
(Apr 2013)
ISSN: 1433-7339 [Electronic] Germany |
PMID | 23111941
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aromatase Inhibitors
- Chondroitin
- Glucosamine
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Topics |
- Adult
- Aged
- Aromatase Inhibitors
(adverse effects)
- Arthralgia
(chemically induced, drug therapy)
- Breast Neoplasms
(drug therapy)
- Chondroitin
(therapeutic use)
- Drug Therapy, Combination
- Female
- Glucosamine
(therapeutic use)
- Hip Joint
- Humans
- Knee Joint
- Middle Aged
- Surveys and Questionnaires
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