Abstract
BackgroundAromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed.Methods/designTo determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks.DiscussionThe results of this study will provide a new strategy to help relieve AIMSS.Trial registrationISCTN: ISRCTN06129599 (assigned 14 August 2013).
Highlights
Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer
Informed consent will be obtained from all participants before randomization
Eligible patients will be randomized into the Yi Shen Jian Gu granules (YSJG) group or the placebo group by obtaining medicines associated with the given drug codes in accordance with the order of visits
Summary
Third-generation aromatase inhibitors (AIs; that is, anastrozole, letrozole and exemestane) have become the standard of care for the adjuvant treatment of hormoneresponsive breast cancer in postmenopausal women. Ethical issues The trial will be conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Clinical Research, and the trial protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University (ref: 201337). This trial was registered with ISRCTN at Current Controlled Trials (ISRCTN06129599).
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