Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

• ClinicalTrials.gov Identifier: NCT03495674
• Recruitment Status: Active, not recruiting
• First Posted: April 12, 2018
• Last Update Posted: July 13, 2022
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: April 4, 2018
• First Posted Date: April 12, 2018
• Last Update Posted Date: July 13, 2022
• Actual Study Start Date: April 4, 2018
• Estimated Primary Completion Date: December 21, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 9, 2019)

• Recruitment rate [ Time Frame: 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%.
• Adherence rate [ Time Frame: 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%.
• Retention [ Time Frame: 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%.

Original Primary Outcome Measures (submitted: April 4, 2018)

Feasibility of a 12-Month Exercise Cycling Intervention Among Lynch Syndrome Patients Feasibility will be evaluated with recruitment (in terms of eligibility and consent), retention and adherence rates. [ Time Frame: Baseline up to 390 days ]

Feasibility evaluated with recruitment (in terms of eligibility and consent), retention and adherence rates. Study considered as feasible if the recruitment rate is at least 20%, along with at least 75% for both adherence and retention rates.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome
• Official Title: CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

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

Intervention

• Behavioral: Exercise Intervention
  Complete cycling classes
• Other: Informational Intervention
  Receive information about exercise guidelines
• Device: Monitoring Device
  Wear Fitbit
  Other Name: Monitor
• Other: Questionnaire Administration
  Complete questionnaire

Study Arms

• Experimental: Group I (FITBIT, cycling)
  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.
  Interventions:

  • Behavioral: Exercise Intervention
  • Device: Monitoring Device
  • Other: Questionnaire Administration
• Active Comparator: Group II (FITBIT, information)
  Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 13, 2019): 21
• Original Estimated Enrollment (submitted: April 4, 2018): 20
• Estimated Study Completion Date: December 21, 2023
• Estimated Primary Completion Date: December 21, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03495674
• Other Study ID Numbers: 2017-1035; NCI-2018-01046 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2017-1035 ( Other Identifier: M D Anderson Cancer Center )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Eduardo Vilar-Sanchez, BLS,MD,PHD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: July 2022