Research Group
Gastrointestinal and Other Cancers
Sponsor
University of Michigan Rogel Cancer Center
Status
Not yet recruiting
NCT ID
NCT06641310
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.
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.
Intervention
Endurance Exercise Therapy
Condition
Familial Adenomatous Polyposis
Investigators
Samara Rifkin, Carol A. Burke, Arnold Markowitz, Catherine Lee, Rashad Spruill, Kirsten Tuck
CT Research Area
Prevention