Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06641310

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Led by University of Michigan Rogel Cancer Center · Updated on 2026-04-29

32

Participants Needed

2

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University of Michigan Rogel Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with Familial Adenomatous Polyposis (FAP) defined by either genetic diagnosis of APC germline mutation or clinical diagnosis with over 50 colorectal adenomas
  • Intact rectum after colectomy and ileocolonic anastomosis or pre-colectomy
  • At least 5 rectal polyps larger than 2 mm on baseline lower endoscopy
  • No invasive cancer evidence for 6 months before screening and at least 6 months since any cancer treatment
  • No new daily use of sulindac, celecoxib, or other NSAIDs within 3 months prior to the study and minimal use during study
  • No new use of semaglutide, liraglutide, tirzepatide, orlistat, or other weight loss drugs within 3 months prior and during study
  • Adults aged 18 years or older
  • HIV patients on effective antiretroviral therapy with undetectable viral load within 6 months
  • Participants with chronic hepatitis B must have undetectable viral load on therapy if needed
  • Participants cured of hepatitis C or with undetectable viral load if on treatment
  • Participants on suppressive antiviral therapy for herpes simplex virus
  • Women of child-bearing potential must use adequate contraception during the study until after final endoscopy
  • Physically inactive defined as 60 minutes or less of moderate or strenuous exercise per week in the past month
  • No self-reported contraindications to regular exercise
  • Sufficient space for treadmill at home or approved access to treadmill
  • Ability for study team to deliver and install exercise equipment or use approved treadmill
  • Internet or Wi-Fi access, or provided cellular iPad
  • Willingness and ability to comply with study visits, treatments, tests, and procedures
  • Physician approval
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • History of total proctocolectomy
  • High-grade dysplasia or cancer found on biopsy at screening
  • History of pelvic radiation
  • Receiving any other investigational agents
  • Uncontrolled illness such as symptomatic heart failure, unstable angina, cardiac arrhythmias, or psychiatric/social conditions limiting compliance
  • Severe or uncontrolled kidney, urinary, liver, blood, hormone, heart, vascular, lung, rheumatologic, nerve, mental health, or metabolic disorders
  • Pregnant women due to contraindication of endoscopy during pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

2

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP) | DecenTrialz