NCT03495674Completed
Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome
CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 4 Apr 2018
- Start date
- 4 Apr 2018
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Colorectal cancer
- NCT number
- NCT03495674
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 4 Apr 2018 to the primary completion date, 2 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum).
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.