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New treatment option for Familial Adenomatous Polyposis
Official title Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)
ClinicalTrials.gov ID: NCT06641310
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 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
- 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...
- History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and...
- Pregnant women are excluded since endoscopy is not recommended while pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.