Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

Not Applicable

Completed

• Conditions: High-Frequency Microsatellite Instability; Mutation-Negative Lynch Syndrome; Mutation-Positive Lynch Syndrome; Mismatch Repair Gene Mutation
• Interventions: Other: Informational Intervention; Behavioral: Exercise Intervention; Device: Monitoring Device; Other: Questionnaire Administration

• Registration Number: NCT03495674
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study Start: 2018-04-04
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-12
• Status Verified: 2024-01
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Participants must have Lynch syndrome defined as meeting any of the following: (1) Mutation-positive Lynch syndrome: carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the deoxyribonucleic acid (DNA) mismatch repair (MMR) genes (i.e. MLH1, MSH2/EPCAM, MSH6, or PMS2) or (2) Mutation-negative Lynch syndrome: patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e. polyp) or a non sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite instability high by either immunohistochemistry or microsatellite instability (MSI) testing or both, but no evidence of MLH1 promoter methylation in cases with loss of both MLH1 and PMS2, and/or no evidence of BRAF mutation in cases with loss of both MLH1 and PMS2) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic testing.
• Participants must not have evidence of active/recurrent malignant disease for a minimum of 6 months.
• Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).
• Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e. participants must have at least part of the descending/sigmoid colon and/or rectum intact).
• Participants must consent to two standard of care lower gastro-intestinal GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies that will be 12 months (+/-21 days) apart.
• Ability to understand and the willingness to sign a written informed consent document.
• Must have normal cardiopulmonary exercise test prior to exercise participation.

Exclusion Criteria

• Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum).
• Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization, arrhythmia requiring treatment such as atrial fibrillation, congestive heart failure, peripheral vascular disease, pulmonary embolism, or deep venous thrombosis.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Individuals with a history of diabetes, hypertension, or have smoked cigarettes in the last 12 months.
• Individuals who are unable to participate in cycling due to musculoskeletal limitations.
• Individuals who are unable to identify cycling classes in their community for exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I (FITBIT, cycling)	Questionnaire Administration	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 (FITBIT, information)	Informational Intervention	Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
Group II (FITBIT, information)	Monitoring Device	Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
Group I (FITBIT, cycling)	Exercise Intervention	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 (FITBIT, information)	Questionnaire Administration	Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
Group I (FITBIT, cycling)	Monitoring Device	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.

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Up to 1 year	Defined as the proportion of eligible patients who consent to the number of patients who are contacted. This study will be considered as feasible if the recruitment rate is at least 20%.
Retention	Up to 1 year	Defined as the proportion of participants who stay until study completion. This study will be considered as feasible if the retention rate is at least 75%.
Adherence rate	Up to 1 year	Defined as the proportion of the actual attendance number to the planned number of exercise sessions (12 sessions monthly x 12 months) where patients will be required to comply with duration (time) of each session participated as well as monthly attendance. This study will be considered as feasible if the adherence rate is at least 75%.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States