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Exercise Therapy for Familial Adenomatous Polyposis (FAP)

This study is testing how different amounts of exercise therapy, specifically treadmill walking, might help prevent colorectal polyps from coming back in people with Familial Adenomatous Polyposis (FAP). FAP is a genetic condition that causes many polyps (growths) in the colon and rectum. You might be able to join if you are 18 or older, have FAP (either through genetic testing or a history of many polyps), and have at least 5 rectal polyps larger than 2 mm. The study aims to see if participants can stick to the exercise plan over 4-12 weeks. The study status is unclear and it plans to enroll 32 people.

Study design
This is an interventional study with an unclear phase, planning to enroll 32 participants. It involves following one of four different exercise regimens on a treadmill for 26 weeks.
What's involved
You would follow a personalized exercise regimen on a treadmill at home for 26 weeks, monitored remotely. In-person visits occur during your usual endoscopy exam and a follow-up exam 26 weeks later, involving questionnaires, stool samples, blood samples, and small rectal tissue biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 26 weeks, with an endpoint for compliance measured between 4-12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06641310

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Recruiting
NAAges 18+InterventionalPrevention
University of Michigan Rogel Cancer Center
~32 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Exercise Therapy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Exercise therapy compliance (feasibility)
Measured over between 4-12 weeks

Conditions

Familial Adenomatous Polyposis

Explore related trials

Familial Adenomatous PolyposisAPC Gene

NCT06641310

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic Foundation

    Cleveland, Ohiostudy coordinator listed

    Not yet recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Samara Rifkin, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
  • Lee Jones, Ph.D · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
  • Carol Burke, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Kirsten Tuck
[email protected]
734-763-1141
Email the study team

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Eligibility criteria

Inclusion

Individuals with FAP as defined by:
Genetic diagnosis: APC germline mutation (with or without FAP family history), OR
Clinical diagnosis: FAP phenotype with a history of more than 50 colorectal adenomas
Have an intact rectum defined as status post colectomy and ileocolonic anastomosis for polyposis or pre-colectomy
≥ 5 rectal polyps \> 2 mm in size on baseline lower endoscopy
Participants must have no evidence of invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)
No initiation of daily use of sulindac, celecoxib or other non-steroidal anti-inflammatory medications (NSAIDs) within 3 months of day 1 and no initiation \> 25% of the time (\> 8 days/month) for the duration of study participation
No initiation of semaglutide, liraglutide (glucagon-like peptide-1 receptor agonist \[GLP-1 receptor agonist\]), tirzepatide (glucose-dependent insulinotropic polypeptide \[GIP\]), orlistat (lipase inhibitor) or other weight loss medications, within 3 months of day 1 and during study participation
Adults ≥ 18 years of age
Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
Lower endoscopy, required for participation in the study, is contraindicated in pregnancy. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and until after the end of study endoscopy is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the study team immediately
Inactive defined as ≤ 60 minutes of moderate or strenuous exercise per week over the past month as assessed by the Godin Leisure Time Exercise Questionnaire
No self-reported contraindications to regular exercise as evaluated by the Physical Activity Readiness Questionnaire (PAR-Q+)
Sufficient space to house a treadmill in primary residence for the intervention period or access to an approved treadmill (as determined by study exercise physiologist) for the intervention period (e.g., participant may have access to a treadmill via an existing membership to a health club)
Ability for study team to deliver and install exercise equipment in primary residence
Internet or Wi-Fi connection. For participants without internet or Wi-Fi, a pre-paid cellular iPad will be provided
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Physician approval
Ability to understand and willingness to sign a written informed consent document

Exclusion

History of total proctocolectomy
Histologically-confirmed high-grade dysplasia or cancer on biopsy at screening
History of pelvic radiation
Participants receiving any other investigational agents
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof
Pregnant women are excluded since endoscopy is not recommended while pregnant

What this trial measures

  • Exercise therapy compliance (feasibility)between 4-12 weeks

    Compliance to the planned treatment regimen will be evaluated by the ratio of completed versus planned level of exercise therapy at each level tested.