Exercise Training Influences Inflammatory and Immune Systems in Patients at High Risk for Colorectal Cancer: The CYCLE-P Study

This CYCling Lynch patients for Exercise and Prevention (CYCLE-P) trial was a prospective, non-randomized controlled trial conducted at the Familial High-Risk Gastrointestinal and Cancer Prevention Clinic of The University of Texas MD Anderson Cancer Center. Twenty-one LS participants with a confirmed pathogenic mutation in one of four DNA mismatch repair (MMR) genes were enrolled between April 2018 and January 2019. Follow-up was conducted 1-year from the start of the intervention. Statistical analysis by both per-protocol and intention-to-treat was performed from March to May 2021. CYCLE-P was a prospective, non-randomized controlled trial that enrolled 21 consecutive participants diagnosed with LS in a 12-month aerobic exercise intervention involving cycling classes in a local community (n=11) followed by enrollment of patients to usual care (n=10) between April 2018 to January 2019. All eligible participants provided written informed consent before enrollment, and the conduction of the trial complied with the Declaration of Helsinki. The trial protocol and all amendments were approved by the MD Anderson Cancer Center institutional review board. We followed the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) reporting guidelines.