Effect of a 1-year tailored exercise program according to cancer trajectories in patients with breast cancer: study protocol for a randomized controlled trial

Abstract

Background Patients with breast cancer undergo various treatments according to their tumor subtype and cancer stages within 1 year after being diagnosed. Each treatment may cause treatment-related symptoms that have negative impacts on patients’ health and quality of life (QoL) The symptoms can be mitigated when exercise interventions are appropriately applied to patients’ physical and mental conditions. Although many exercise programs were developed and implemented during this period, the effects of tailored exercise programs according to symptoms and cancer trajectories on patients’ long-term health outcomes have not yet been fully elucidated. Therefore, this randomized controlled trial (RCT) aims to investigate the effect of tailored home-based exercise programs on short-term and long-term physiological outcomes in patients with breast cancer. Methods This 12-month RCT includes 96 patients with (stages 1–3) breast cancer randomly assigned to the exercise or control groups. Participants in the exercise group will receive an exercise program tailored to their phase of treatment, type of surgery, and physical function. During post-operative recovery, exercise interventions will be emphasized to improve shoulder range of motion (ROM) and strength. During chemoradiation therapy, exercise intervention will focus on improving physical function and preventing loss of muscle mass. Once chemoradiation therapy is completed, exercise intervention will focus on improving cardiopulmonary fitness and insulin resistance. All interventions will be home-based exercise programs supplemented with once-monthly exercise education and counseling sessions. The main outcome of the study is fasting insulin level at baseline, 6 months, and 1 year post-intervention. Our secondary outcomes include shoulder ROM and strength at 1 month and 3 months, body composition, inflammatory markers, microbiome, QoL, and physical activity levels at 1 month, 6 months, and 1 year post-intervention. Conclusion This trial is the first tailored home-based exercise oncology trial to better understand the comprehensive phase-dependent short- and long-term effects of exercise on shoulder function, body composition, fasting insulin, biomarkers, and microbiome. The results of this study will inform the development of effective exercise programs tailored to the needs of patients with breast cancer post-operatively. Trial registration The protocol for this study is registered with the Korean Clinical Trials Registry (KCT0007853).

Improved awareness of physical activities is associated with a gain of fitness and a stable body weight in breast cancer patients during the first year of antineoplastic therapy: the BEGYN-1 study

“…Thus, according to the guidelines ( 7 , 39 , 40 ), patients were advised to engage in moderate physical activity, but no upper limit was mentioned. Even though, none of the BEGYN-1 study patients showed any sign of overexertion or other negative side effects of too much physical activity, further research is needed to individualize recommendations for the level of physical activity to aim for ( 50 , 51 ). The increased physical activity and fitness achieved in the BEGYN-1 study might have multiple other consequences that are known to be associated with increased physical activity in breast cancer patients, e.g., increased bone health ( 52 ), reduced cancer related fatigue ( 53 ), and reduced cancer related cognitive impairment ( 54 ).…”

Incorporating Exercise Training into Cardio-Oncology Care

“…Studies looking at implementing remote or unsupervised exercise programs in a variety of cancer populations have been proposed and/or are ongoing. 85 , 94 , 95 , 96 , 97 …”