Abstract

Abstract Purpose: Arthralgia sometimes occurs in the breast cancer patients treated with aromatase inhibitors (AIs). It is one of the most important reasons for poor AIs adherence. Background; The HOPE study previously demonstrated that exercise was effective in improving AI-induced arthralgia in breast cancer patients. However, recruitment to this study was limited to severe cases (Criteria; physically inactive, >6 months AT treatment, >2 months arthralgia). To asses if these findings were more generalizable to all breast cancer contexts we conducted a randomized trial of exercise intervention using wider eligibility criteria that the hope study to assess the impact on AI induced arthralgia in breast cancer patients. Methods: We examined Japanese breast cancer patients operated at Nahanishi Clinic, Okinawa, Japan. Following the informed consent the patients were randomly assigned to a 3:1 ratio to exercise intervention or usual care, . Eligibility criteria included receiving an AI for 0-4 years, no metastases, any arthralgia level and any exercise habits. Following randomization participants could choose from 3 types of exercise including strong (120-150 minutes per week of walking or running), intermediate (gentle calisthenics (daily NIPPON HOSO KYOKAI: NHK broadcast exercise)) and weak (going up the stairs- frequency). Arthralgia was assessed using the Brief Pain Inventory (BPI), in which the patients completed a baseline, 6month and 12 month BPI assessment. Primary endpoint was BPI change at 12 months. Results: Among 227 women screened, we randomized 108 women, with 80 to exercise intervention (46 of strong, 19 of intermediate and 15 of weak) and 28 to usual care. Base line BPI were well balanced between exercise intervention and usual care. Overall exercise intervention reduced BPI scores relative to control. The BPI changes of worst pain, least pain, average pain and pain right now were 0.09, -0.25, -0.14 and 0 for exercise intervention group and 0.21, 0.46, 0.07 and 0.61 for usual care group, respectively. There was a statistically significant difference of AIs adherence between exercise intervention group (99%) and usual care group (92%) (P=0.03). Conclusion: Exercise intervention tends to improve the AI-induced arthralgia and has a positive effect on AIs adherence. Citation Format: Tajaesu M, Tamaki K, Nagamine S, Kamada Y, Uehara K, Arakaki M, Tamatsu Y, Yamashiro K, Miyashita M, Ishida T, Ohuchi N, McNamara K, Terukina S, Sasano H, Tamaki N. Randomized trial of exercise intervention vs. usual care for breast cancer patients with aromatase inhibitor to prevent and improve the aromatase inhibitor induced arthralgia [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-12-01.

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