High-Frequency Microsatellite Instability Clinical Trial
Official title:
CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
This trial studies how well cycling works in preventing colorectal cancer in participants with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in participants with Lynch syndrome.
PRIMARY OBJECTIVES: I. To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome (LS) patients. SECONDARY OBJECTIVES: I. To assess the effect size of exercise on circulating biomarkers as well as regulation of genomic, transcriptomic, and immunologic biomarkers in normal intestinal mucosa of LS patients. OUTLINE: Participants are assigned to 1 of 2 groups. GROUP I: Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year. GROUP II: Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year. After completion of study interventions, participants are followed up at 30 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03436563 -
M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability
|
Phase 1/Phase 2 |