治験レーダー

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