Abstract GS4-04: Randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in women with early stage breast cancer (S1200)

Abstract

Abstract Background: Musculoskeletal symptoms are the most common side effect of aromatase inhibitors (AIs) and can result in decreased quality of life and discontinuation of therapy. Pilot data from two prior single institution studies showed that acupuncture decreased AI-induced joint symptoms in breast cancer (BC) patients. Methods: We conducted a SWOG multicenter randomized controlled trial among postmenopausal women with early stage BC. Patients taking an AI for ≥30 days and having a worst pain score of ≥3 out of 10 using the Brief Pain Inventory (BPI-WP) were eligible. Subjects were randomized at a 2:1:1 ratio to true acupuncture (TA) vs. sham acupuncture (SA) vs. waitlist control (WC). The TA protocol used a standardized protocol of body and auricular acupoints tailored to joint symptoms. The similarly standardized SA protocol utilized superficial needling of non-acupoints. Both the TA and SA protocols consisted of a 12 week intervention, with 12 sessions administered over 6 weeks, followed by 1 session per week for 6 additional weeks. The primary endpoint was change in the BPI-WP (worst pain) score at 6 weeks. Secondary outcomes included other BPI scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for the hips and knees, the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), and functional testing with grip strength and "Timed Get Up and Go" (TGUG). The design specified alpha=.025 two-sided tests to account for two independent comparisons (TA vs. SA and TA vs. WC). Results: Among 226 patients registered, 110 were randomized to TA, 59 to SA and 57 to WC. Baseline characteristics were similar between the groups. In a linear regression adjusting for the baseline score and stratification factors, 6-week mean BPI-WP scores were 0.92 points lower (correlating with less pain) in the TA compared to SA arm (95% CI: 0.20-1.65, p=.01), and were 0.96 points lower in the TA compared to WC arm (95% CI: 0.24-1.67, p=.01). The proportion of patients experiencing a clinically meaningful (>2) reduction (i.e. improvement) in BPI-WP was 58% for TA compared to 33% on SA and 31% on WC. Patients randomized to TA had improved symptoms compared to SA at week 6 according to all other BPI pain measures (average pain, p=.04; pain interference, p=.02; pain severity, p=.05; worst stiffness, p=.02). Results were similar compared to WC. Patients randomized to TA compared to SA or WC had statistically significant or marginally statistically significant improvements in BPI pain measures at week 12. Patients randomized to TA had generally improved symptoms compared to SA or WC at week 6 and at week 12 according to the M-SACRAH and WOMAC measures (p<0.05). With regard to adverse events, more patients on the TA arm experienced Grade 1 bruising compared to SA (47% vs. 25%, p=.01). No other differences by arm for selected adverse events were observed. Conclusions: This study was the first large multicenter trial to investigate the effect of acupuncture in treating AI-induced joint symptoms in BC patients. According to multiple measures, TA generated better outcomes than either SA or WC with minimal toxicity. Citation Format: Hershman DL, Unger JM, Greenlee H, Capodice J, Lew DL, Kengla AT, Melnik MK, Jorgensen CW, Kreisle WH, Minasian LM, Fisch MJ, Henry L, Crew KD. Randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in women with early stage breast cancer (S1200) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr GS4-04.