Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

NCT03495674 | Completed

• 2 other identifiers: 2017-1035NCI-2018-01046
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  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%.

  Up to 1 year

• Adherence rate

  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%.

  Up to 1 year

• Retention

  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%.

  Up to 1 year

Study Arms (2)

Group I (FITBIT, cycling)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Device: Monitoring Device; Other: Questionnaire Administration

Group II (FITBIT, information)

ACTIVE COMPARATOR

Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.

Other: Informational Intervention; Device: Monitoring Device; Other: Questionnaire Administration

Interventions

Exercise Intervention BEHAVIORAL

Complete cycling classes

Group I (FITBIT, cycling)

Informational Intervention OTHER

Receive information about exercise guidelines

Group II (FITBIT, information)

Monitoring Device DEVICE

Wear Fitbit

Also known as: Monitor

Group I (FITBIT, cycling); Group II (FITBIT, information)

Questionnaire Administration OTHER

Complete questionnaire

Group I (FITBIT, cycling); Group II (FITBIT, information)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eduardo Vilar-Sanchez, BLS,MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 12, 2018
• Study Start: April 4, 2018
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)