Recruiting

Exercise Regimen

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06641310

Conditions

Familial Adenomatous Polyposis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Therapy

Study Details

Brief 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.

Conditions

Familial Adenomatous Polyposis

Study ID

NCT06641310

Start date

May 13, 2026

Status verified date

May, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • 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

  • Note: If participant will be using treadmill from another source approved by study exercise physiologist, this inclusion criteria is not applicable
  • 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 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Exercise therapy comprising treadmill walking

exercise therapy

Interventions

Exercise Therapy

Exercise therapy comprising treadmill walking will be administer by exercise physiologists via a study-kit which includes a smart-watch (activity tracker), heart rate monitor, blood pressure cuff, body composition scale, and e-tablet for remotely monitoring your exercise. The trials will test 3 exercise levels (150, 225, and 300 minutes per week), with one de-escalation exercise level of 90 minutes per week if needed.

Primary outcome measure

  • Exercise therapy compliance (feasibility) [ Time Frame: between 4-12 weeks ]

Central Contacts and Locations

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kirsten Tuck

734-763-1141KLtuck@med.umich.edu

Principal Investigator:

Samara Rifkin

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-05-19.