Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer
| Autor: | Theresa Shao, Katherine D. Crew, Lois Brafman, Grace Kranwinkel, Heather Greenlee, Dawn L. Hershman, Kevin Kalinsky, Beverly J. Insel, Matthew Maurer, Wei-Yann Tsai |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
medicine.medical_specialty Knee Joint medicine.drug_class Phases of clinical research Breast Neoplasms Article chemistry.chemical_compound Pharmacotherapy Breast cancer Glucosamine Surveys and Questionnaires Internal medicine medicine Humans Chondroitin Aged Aromatase inhibitor Aromatase Inhibitors business.industry Middle Aged medicine.disease Arthralgia Clinical trial Endocrinology Oncology chemistry Drug Therapy Combination Female Hip Joint business Hormone |
| Zdroj: | Supportive Care in Cancer. 21:1077-1087 |
| ISSN: | 1433-7339 0941-4355 |
| DOI: | 10.1007/s00520-012-1628-z |
| Popis: | Many women with hormone receptor-positive breast cancer discontinue effective aromatase inhibitor (AI) treatment due to joint symptoms.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.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 %).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. |
| Databáze: | OpenAIRE |
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