Abstract P2-13-02: Phase II Study of Glucosamine with Chondroitin on Joint Symptoms Induced by Aromatase Inhibitors in Breast Cancer Patients

Abstract

Abstract Background: Aromatase inhibitors (AIs) are commonly used as adjuvant endocrine therapy in postmenopausal women with hormone receptor-positive breast cancer (BC). However, many patients treated with AIs experience joint symptoms which may lead to non-adherence to treatment. We examined whether glucosamine plus chondroitin improves AI-induced arthralgias in women with early stage BC. Methods: This is a single-arm Phase II study evaluating the efficacy of glucosamine and chondroitin in postmenopausal BC patients with moderate to severe AI-induced arthralgias. Patients took glucosamine sulfate (1500mg/d) + chondroitin sulfate (1200mg/d) for 24 weeks, and were assessed every 6 weeks. The primary endpoint was change in Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria at 24 weeks. Secondary endpoints include changes in Brief Pain/Stiffness Inventory-Short Form (BPI-SF), Western Ontario and McMaster Universities Osteoarthritis (WOMAC), Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), quality of life, grip strength and estradiol level. A Simon two-stage design was used. If 7/22 responses were observed, the trial would continue. Results: Of 36/46 patients enrolled to date, 21 were evaluable at 24 weeks. Median age: 61 (46-80); White/Hispanic/Black/Asian: 11/5/4/1. At 24 weeks, 12/21 patients (57%) had improved pain/stiffness or function in their knees or hips, and 14/21 patients (67%) had improvement in their hands, and 80% had improvement in hands and/or knees. There were also decreases in BPI pain/stiffness severity and functional interference (P<0.05). Reassuringly, there was no increase in serum estradiol levels. Conclusion: Glucosamine and chondroitin is a well-tolerated and potentially effective treatment for AI-induced arthralgia. Evaluation of these agents in a placebo controlled phase III study is warranted. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-13-02.