Familial Adenomatous PolyposisNCT06641310
Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)
A study testing Exercise Therapy in people with Familial Adenomatous Polyposis, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- Exercise Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 23Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Kirsten Tuck, 734-763-1141, KLtuck@med.umich.edu
Samara Rifkin
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Rashad Spruill, 216-444-1815, SPRUILR@ccf.org
Carol A. Burke
About this study
Official title: Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)
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
- Being tested
- Exercise Therapy
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy comprising treadmill walking | Experimental | exercise therapy Receives: Procedure: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 4-12 weeks
Secondary outcomes (1)
Physiological changes
Exercise capacity will be evaluated by a sub-maximal exercise capacity test.
Measured: Baseline up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Samara Rifkin, MD, Principal investigator, University of Michigan Rogel Cancer CenterLee Jones, Ph.D, Principal investigator, City of Hope Medical CenterCarol Burke, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641310
- Sponsor's protocol ID
- UMCC 2024.083
- Other IDs
- NCI-2023-10925, HUM00256140, UMI23-15-01, UG1CA242632
- Status last verified
- May 2026
- First submitted
- 8 Oct 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)
- ClinicalTrials.gov ID
- NCT06641310
- Acronym / sponsor ID
- UMCC 2024.083
- Conditions
- Familial Adenomatous Polyposis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy comprising treadmill walking | Experimental | Procedure: Exercise Therapyexercise therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Individuals with FAP as defined by:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyExercise 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. | Procedure or surgery | Exercise therapy comprising treadmill walking |
Primary outcome
Exercise therapy compliance (feasibility)
Time frame: between 4-12 weeks
Compliance to the planned treatment regimen will be evaluated by the ratio of completed versus planned level of exercise therapy at each level tested.
1 secondary outcome
Physiological changes
Time frame: Baseline up to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Only aggregate data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samara Rifkin, MD principal investigator
University of Michigan Rogel Cancer Center
Lee Jones, Ph.D principal investigator
City of Hope Medical Center
Carol Burke, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy in people with Familial Adenomatous Polyposis, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise therapy compliance (feasibility) (time frame: between 4-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.