Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

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 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
• •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