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CompletedNCT03495674Updated Jan 5, 2024

Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

An interventional study of Exercise Intervention and Informational Intervention in High-Frequency Microsatellite Instability, Mismatch Repair Gene Mutation and Mutation-Negative Lynch Syndrome, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • High-Frequency Microsatellite Instability
  • Mismatch Repair Gene Mutation
  • Mutation-Negative Lynch Syndrome
  • Mutation-Positive Lynch Syndrome
03

In context

Colorectal Neoplasms, Hereditary Nonpolyposis

145 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 59 are open to participants now.

This study's enrollment of 21 is below the median of 200 across 75 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.

Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Browse M.D. Anderson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 that will be 12 months (+/-21 days) apart.
  • Ability to understand and the willingness to sign a written document.
  • Must have normal cardiopulmonary exercise test prior to exercise participation.

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

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.

    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.

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

Interventions

  • BehavioralExercise Intervention

    Complete cycling classes

  • OtherInformational Intervention

    Receive information about exercise guidelines

  • DeviceMonitoring Device

    Wear Fitbit

    Also known as: Monitor

  • OtherQuestionnaire Administration

    Complete questionnaire

06

What researchers measure

Primary outcomes

  1. 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%.

    Time frame: Up to 1 year

  2. 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%.

    Time frame: Up to 1 year

  3. 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%.

    Time frame: Up to 1 year

07

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jan 2024, 68 months.

Of 37 interventional studies with no phase under Colorectal Neoplasms, Hereditary Nonpolyposis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 86. This study's 68 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2018
First posted
Apr 12, 2018
StartActual
Apr 4, 2018
Primary completionActual
Jan 2, 2024
CompletionActual
Jan 2, 2024
Last update
Jan 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03495674
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
Apr 4, 2018
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024
Last update
Jan 5, 2024

Study contacts

Eduardo Vilar-Sanchez, BLS,MD,PHD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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