Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of exercise therapy, specifically supervised treadmill walking, on individuals with Familial Adenomatous Polyposis (FAP), a genetic condition that can lead to colon cancer. The main goal of the trial is to determine the best amount of exercise for future studies. Participants will be assigned to different levels of exercise, ranging from 90 to 300 minutes per week, to see which level works best for them.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of FAP, which can be either genetic or clinical. They should also have at least five rectal polyps larger than 2 mm and have no evidence of invasive cancer for six months before joining the study. Participants will need to commit to regular exercise, have access to a treadmill, and be able to attend scheduled visits for the study. Women who can become pregnant must use effective birth control during the trial. The study is not yet recruiting, but it aims to provide valuable information about how exercise can help manage FAP and improve health outcomes.

Gender

ALL

Eligibility criteria

• 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