NCT03495674

Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

CYCling Lynch Patients for Exercise and Prevention: CYCLE-P

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• High-Frequency Microsatellite Instability
• Mismatch Repair Gene Mutation
• Mutation-Negative Lynch Syndrome
• Mutation-Positive Lynch Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Complete cycling classes
OTHER	Informational Intervention	Receive information about exercise guidelines
DEVICE	Monitoring Device	Wear Fitbit
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2018-04-04
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2018-04-12
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States