Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

NCT06641310 | Recruiting DMC

• 5 other identifiers: UMCC 2024.083NCI-2023-10925HUM00256140UMI23-15-01UG1CA242632
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Exercise therapy compliance (feasibility)

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

  between 4-12 weeks

Secondary Outcomes (1)

• Physiological changes

  Baseline up to 26 weeks

Other Outcomes (5)

• Change in the proliferation and apoptosis

  up to 27 weeks

• Change in the proliferation / apoptosis ratio

  up to 27 weeks

• Change in rectal polyp burden

  up to 27 weeks

Study Arms (1)

Exercise therapy comprising treadmill walking

EXPERIMENTAL

exercise therapy

Procedure: Exercise Therapy

Interventions

Exercise Therapy PROCEDURE

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.

Exercise therapy comprising treadmill walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Samara Rifkin, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• Lee Jones, Ph.D

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

• Carol Burke, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)