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.
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
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
Single group
Exercise Therapy
Procedure/SurgeryExercise 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.
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.
Physiological changes
Exercise capacity will be evaluated by a sub-maximal exercise capacity test.
Change in the proliferation and apoptosis
To evaluate change in the proliferation and apoptosis in rectal adenomas and normal appearing rectal mucosa from baseline to end of treatment
Change in the proliferation / apoptosis ratio
To evaluate change in the proliferation / apoptosis ratio in rectal adenomas and normal appearing rectal mucosa from baseline to end of treatment
Change in rectal polyp burden
To evaluate the change in rectal polyp burden from baseline to end of treatment
Changes in body composition
To evaluate physiological response to exercise therapy as evaluated by changes in body composition
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University of Michigan Rogel Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
