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Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer.

AbstractPURPOSE:
Many women with hormone receptor-positive breast cancer discontinue effective aromatase inhibitor (AI) treatment due to joint symptoms.
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.
AuthorsHeather Greenlee, Katherine D Crew, Theresa Shao, Grace Kranwinkel, Kevin Kalinsky, Matthew Maurer, Lois Brafman, Beverly Insel, Wei Yann Tsai, Dawn L Hershman
JournalSupportive 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
PMID23111941 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Aromatase Inhibitors
  • Chondroitin
  • Glucosamine
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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