A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results.

Background: Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, recruitment, and exercise adherence results of the National Cancer Institute (NCI)-sponsored Exercise and Colorectal Cancer Treatment (EXACT) trial.

Methods: The primary objective of the EXACT trial is to determine if randomization to 150 min per week of moderate-intensity aerobic exercise reduces systemic inflammation among stage I-III colorectal cancer survivors compared with a waitlist control group over 12 weeks. Participants were provided with an in-home treadmill and heart rate monitor. Characteristics associated with randomization were identified using χ or Fisher's exact test for categorical variables and t-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed.

Results: Between August 2019 and February 2023, 3082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (P = 0.02), female sex (P = 0.002), white race (P = 0.01), proximal time since tumor resection (P = 0.02), and regional tumor stage (P < 0.001) were associated with study participation. Average exercise adherence was 92.2 % (95 % CI: 85.5, 98.8) and all study participants achieved ≥80 % exercise adherence. Endpoint data collection was completed for all participants in May 2023.

Conclusion: The results from the EXACT trial will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.