Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer

OBJECTIVES:

Primary

• To determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain related to aromatase inhibitors (AIs) in women with early-stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.

Secondary

• To investigate the effects of true acupuncture administered twice weekly for 6 weeks (8-12 sessions) followed by 6 weekly treatments (4-6 sessions) of maintenance (12-18 sessions total over 12 weeks) compared to sham acupuncture and waitlist control in this study population; the evaluations at 12 and 24 weeks are to determine the benefit of additional 6 weekly acupuncture treatments for maintenance and to determine the durability of response after stopping acupuncture, respectively; the evaluation at 52 weeks is to determine the long-term effects of acupuncture and adherence to AIs.
• To evaluate the effects of acupuncture on the BPI-SF worst pain, worst stiffness, pain severity, and pain-related interference scores at 6, 12, 16, 20, 24, and 52 weeks.
• To evaluate the effects of acupuncture on Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index (pain, stiffness, and function) for the hips and knees at 6, 12, 24, and 52 weeks.
• To evaluate the effects of acupuncture on Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) (pain, stiffness, and function) at 6, 12, 24, and 52 weeks.
• To evaluate the effects of acupuncture on the PROMIS Pain Impact-Short Form (PROMIS PI-SF) at 6, 12, 24, and 52 weeks.
• To evaluate the effects of acupuncture on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at 6, 12, 24, and 52 weeks.
• To evaluate the effects of acupuncture on functional testing with grip strength and "Timed Get Up and Go" (TGUG) test at 6, 12, 24, and 52 weeks.
• To evaluate the effects of acupuncture on analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks.
• To evaluate the effects of acupuncture on self-reported AI adherence at 12, 24, and 52 weeks.
• To assess AI adherence via urine AI metabolites at baseline, 24, and 52 weeks.
• To evaluate the effects of acupuncture on serum hormones (estradiol, FSH, LH) and inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP, and urine c-telopeptides of Type II collagen (CTX-II) at 6, 12, and 24 weeks. (Exploratory)
• To evaluate whether polymorphisms in CYP19A1 aromatase gene predict severity of AI-related joint symptoms. (Exploratory)
• To assess the safety and tolerability of acupuncture in this study population.