Clinical Research Directory

AKU Study - Acupuncture for Aromatase Inhibitor-Induced Musculoskeletal Syndrome

Third-generation aromatase inhibitors (AIs) represent a standard adjuvant endocrine treatment for postmenopausal and high-risk premenopausal women with hormone receptor-positive early breast cancer. However, aromatase inhibitor-associated musculoskeletal syndrome (AIMSS)-characterized by joint pain, stiffness, and reduced mobility-occurs in approximately 50% of patients and significantly impairs treatment adherence and patient quality of life. Poor adherence to endocrine therapy is associated with reduced overall survival. The purpose of this prospective, randomized (1:1), open-label, parallel-group clinical trial is to evaluate the efficacy, safety, and duration of therapeutic relief of acupuncture in managing AI-induced musculoskeletal symptoms in female patients with early-stage breast cance. A total of 200 participants experiencing AI-related joint pain are randomized either to receive 10 weekly 20-minute sessions of manual acupuncture over 10 weeks or to a control group receiving standard care without acupuncture. Joint pain severity, upper limb muscle strength and dexterity, sleep quality, and psychological distress are evaluated using validated patient-reported outcomes (Brief Pain Inventory \[BPI\], Rheumatoid Arthritis Pain Scale \[RAPS\], Pittsburgh Sleep Quality Index \[PSQI\], and Hospital Anxiety and Depression Scale \[HADS\]) as well as objective physical performance tests (Hand Grip Strength Test and Grip Ability Test) at baseline, 10 weeks, 14 weeks (4 weeks post-intervention), and 22 weeks (3 months post-intervention).