Abstract OT3-12-02: Effect of physical activity training on cardiovascular function, immune cells, quality of life during breast cancer chemotherapy in Taiwan
Authors: Hsieh Chia-Ming , Lee Kuan-Der , Wu Meng-Hsiu , Yang Ning-Chiang , Chen Hsin-Yi , Tzeng I-Shiang 
Published: March 2020

Background It has been shown that exercise may improve NK cell immune response.In the past decades, several investigations also showed that physical activity training(PAT) during breast cancer treatment was able to maintain cardiorespiratory function and quality of life. This study is aimed to investigate effect of simple PAT on Immune cells changes, cardiorespiratory function and quality of life during breast cancer chemotherapy (CT).Trial designation Breast cancer patients, aged from 20 to 80 years old with stage I, II, III disease, who receive adjuvant or neoadjuvant chemotherapy are candidates for the study. Sixty patients will be recruited, and divided randomly into two arms, exercise interventional arm (n=30) and control arm (n=30). For PAT interventional participants Aerobic and muscular exercises are instructed by a sport trainer to the participants, and the participants are asked to do it at home, including 150 minutes moderate or 75 vigorous physical activity a week, 30 minutes each time. For control participantsOnly PAT manual is distributed to the control participants.

Measurement and Data collection In this study, the following measurements are selected including: 1. Immune cells: lymphocyte subsets(CD3+, CD4+, CD8+, CD56+ T cells, and CD4+/CD8+ ratio) will be measured. Peripheral blood immune cells is analyzed before and 10-14 days after each cycle of adjuvant or neoadjuvant CT(usually 6-8 cycles of CT). 2. Cardiorespiratory function measurement including 6-minute walk test and echocardiography, before the 1st CT and at the end of whole CT courses. 3. Body weight, BMI, waist circumference and body composition assessment (body fat, muscle mass, and basal metabolic rate), WHOQOL are measured before the 1st CT and at end of the whole CT courses. Outcomes

The primary outcome is the change of immune cell member per cycle of CT, and the secondary outcomes are chemotherapy completion rate, on schedule chemotherapy rate, improvement of cardiorespiratory function and quality of life.

Statistical analysis In this study, to achieve a 95% power with 0.05 significance level, 18 subjects are required for each arm and this sample size calculation is based on effect size 0.25 and correlation between repeated measurements of immune cells using repeated measure analysis of variance (ANOVA). As a result, the changes of immune cell number over time will be examined by repeated measure ANOVA.To examine the difference of improvement of cardiorespiratory function and quality of life between 2 arms, 2-sample t-test or the Wilcoxon rank sum test will be used. To compare the chemotherapy completion rate and on-schedule chemotherapy rate, the Chi-square test or Fisher’s exact test will be employed. All statistical analyses will be performed using SPSS 22.0 software. A P value of 0.05 is considered to be significant in all tests

Discussion The study will be started after approval of IRB(The institutional Review Board) in our hospital.

Citation Format: Chia-Ming Hsieh, Kuan-Der Lee, Meng-Hsiu Wu, Ning-Chiang Yang, Hsin-Yi Chen, I-Shiang Tzeng. Effect of physical activity training on cardiovascular function, immune cells, quality of life during breast cancer chemotherapy in Taiwan [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-12-02.