Abstract OT3-07-02: Influence of exercise or educational programs on long-term physical activity by patients after surgery for primary breast cancer: A randomized trial
Authors: Kawada K , Taira N , Hatono M , Takahashi Y , Miyoshi Y , Nogami T , Iwamoto T , Motoki T , Sien T , Matsuoka J , Doihara H , Ikeda M , Ogasawara Y , Takabatake D , Yoshitomi S , Kiyoto S , Yamamoto S , Mizota Y , Oka K 
Published: March 2017

Abstract
[Background]
Past studies revealed that a moderate to high level of physical activity after diagnosis of breast cancer reduces both the risk of breast cancer-related death and death from all causes. Furthermore, some randomized studies suggested that exercise programs improve the percentage of patients who complete the chemotherapy and quality of life, and decrease fatigue, and adverse events. The issues to be determined include defining an established uniform exercise program and the efficacy of a long-term exercise program after breast cancer surgery.
[Object] To elucidate the efficacy of a long-term exercise program and to verify the safety and feasibility of a uniform exercise program using an ‘existing social resource’ after primary therapy of breast cancer.
[Design] A multi-center, randomized trial.
[Method] Subjects: The subjects included patients who had completed treatment for primary breast cancer, including surgery and/or adjuvant chemotherapy. Patients with metastatic breast cancer were excluded.
Randomization & intervention: The patients were randomly assigned to three groups.
The first group followed an exercise program at Curves® that involved 30 minutes of exercise, including aerobics, weight training, and stretching 3 times a week for 4 months. The second group was given life-style guidance at least once that patients participate in a lecture program about recommended exercise at this point and the importance of weight control after diagnosis of breast cancer using a brochure. The third group served as controls that the patients receive a brochure used same one in the second group. The variables included age and weight.
Outcome: The primary endpoint is level of physical activity at 1 year after randomization, and the secondary endpoints are the percentage of those completing the exercise program, patient reported outcomes (QOL, cancer or treatment associated symptoms, fatigue, depression, and anxiety), body mass index, bone density, and level of lymphedema.
Period of research: The study will last 2 years beginning March 2016.
Sample size: We plan to enroll 400 patients to detect 20% difference with 90% power.
Additional study: Some biochemical markers in the blood will be evaluated to determine the mechanism of the effect of exercise on the human body.
Citation Format: Kawada K, Taira N, Hatono M, Takahashi Y, Miyoshi Y, Nogami T, Iwamoto T, Motoki T, Sien T, Matsuoka J, Doihara H, Ikeda M, Ogasawara Y, Takabatake D, Yoshitomi S, Kiyoto S, Yamamoto S, Mizota Y, Oka K. Influence of exercise or educational programs on long-term physical activity by patients after surgery for primary breast cancer: A randomized trial [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 OT3-07-02.