Loading clinical trials...

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP) | Clinical Trials | Clareo Health

RECRUITINGNA

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

NCT06641310•University of Michigan Rogel Cancer Center

Summary

The purpose of this phase 1a/b trial is to find out what amount of exercise would be best to use for preventing recurrence of colorectal polyps. It involves following one of four different amounts of exercise regimens on a treadmill for 26 weeks. A treadmill will be placed in each study participant's home for the duration of the study. The exercise regimen will be personalized for each participant and monitored remotely by exercise personnel. The in-person study visits occur during the usual standard of care endoscopy exam and during a follow-up exam that is 26 weeks later. Small rectal tissue biopsies, about the size of a grain of rice, will be taken before and after 26 weeks of exercise. The study visits also involve questionnaires, a stool sample, and a blood sample. This study will inform the design of larger, future trials to investigate whether or not recurrence of polyps can be achieved with exercise.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+11 more criteria

Exclusion Criteria

•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

Locations (2)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

February 6, 2026

Enrollment

ESTIMATED participants

Conditions

Familial Adenomatous Polyposis

Interventions

Exercise Therapy

PROCEDURE

Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

NCT06950385

Familial Adenomatous Polyposis (FAP)

View study

RECRUITING

Familial Investigations of Childhood Cancer Predisposition

NCT03050268

Acute LeukemiaAdenomatous Polyposis+44 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Inclusion Criteria

Exclusion Criteria

Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis

Familial Investigations of Childhood Cancer Predisposition

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis (MicrobEnvironment in FAP)

The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis

Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer