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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495674
Other study ID # 2017-1035
Secondary ID NCI-2018-0104620
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2018
Est. completion date January 2, 2024

Study information

Verified date January 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 2, 2024
Est. primary completion date January 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  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

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