Trial Summary
What is the purpose of this trial?The study intervention being investigated in this phase 1a/b trial is exercise therapy. The form of exercise therapy will be aerobic exercise therapy comprised of supervised moderate-intensity treadmill walking.
The primary objective of this study is to identify the most appropriate level (the recommended phase 2 dose; RP2D) of exercise therapy for investigation in larger trials. To identify the RP2D of exercise therapy we will conduct a phase 1a level-finding trial and a phase 1b level-expansion trial. The phase 1a study is a level escalation trial evaluating 3 exercise levels (150, 225, and 300 minutes per week), with one de-escalation level of 90 minutes per week, if required. The phase 1b trial will further evaluate the highest feasible level and one LEVEL below identified in the phase 1a study.
Eligibility Criteria
This trial is for individuals with familial adenomatous polyposis, a condition that causes many polyps in the intestine. Participants should be able to perform moderate-intensity exercise but specific inclusion and exclusion criteria are not detailed here.Inclusion Criteria
Inactive defined as ≤ 60 minutes of moderate or strenuous exercise per week over the past month
No self-reported contraindications to regular exercise as evaluated by the PAR-Q+
I am on long-term antiviral treatment for herpes.
+17 more
Exclusion Criteria
Pregnant women
I have had surgery to remove my colon and rectum.
Participants receiving any other investigational agents
+4 more
Participant Groups
The study tests aerobic exercise therapy as a treatment, specifically treadmill walking at different intensities. It aims to find the best dose of exercise (measured in minutes per week) for future larger trials through two phases: level-finding and level-expansion.
1Treatment groups
Experimental Treatment
Group I: Endurance exercise therapy comprising treadmill walkingExperimental Treatment1 Intervention
Endurance exercise therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Michigan Rogel Cancer CenterAnn Arbor, MI
Memorial Sloan Kettering Cancer CenterNew York, NY
Cleveland Clinic FoundationCleveland, OH
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Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator