title: Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Greenlee
authors.forename: Katherine D
authors.initials: KD
authors.lastname: Crew
authors.forename: Theresa
authors.initials: T
authors.lastname: Shao
authors.forename: Grace
authors.initials: G
authors.lastname: Kranwinkel
authors.forename: Kevin
authors.initials: K
authors.lastname: Kalinsky
authors.forename: Matthew
authors.initials: M
authors.lastname: Maurer
authors.forename: Lois
authors.initials: L
authors.lastname: Brafman
authors.forename: Beverly
authors.initials: B
authors.lastname: Insel
authors.forename: Wei Yann
authors.initials: WY
authors.lastname: Tsai
authors.forename: Dawn L
authors.initials: DL
authors.lastname: Hershman
mesh_terms: D000328:Adult; D000368:Aged; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D018771:Arthralgia / Q000139:chemically induced / Q000188:drug therapy*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002807:Chondroitin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005944:Glucosamine / Q000627:therapeutic use*; D006621:Hip Joint; D006801:Humans; D007719:Knee Joint; D008875:Middle Aged; D011795:Surveys and Questionnaires
chemical_list: D047072:Aromatase Inhibitors; D002807:Chondroitin; D005944:Glucosamine