NCT05773144NARecruiting
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
AdventHealth Translational Research Institute
Start Date
6/1/2023
Completion Date
5/1/2027
Summary
To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Age ≥18 years
* Histologically confirmed stage II or III colon cancer
* Completed surgical resection with curative intent
* Plan to initiate chemotherapy
* Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
* No planned major surgery during the study period
* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
* Can walk 400 meters
* Can read and speak English
* Ability to provide written informed consent
* Provide written approval by qualified healthcare professional
* Willing to be randomized
Exclusion Criteria:
* Evidence of metastatic colon cancer
* Concurrently actively treated other (non-colon) cancer
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Currently participating in another study with competing outcomes
* Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Interventions
BEHAVIORAL
Aerobic exercise
BEHAVIORAL
Progressive stretching
Conditions
Colonic Neoplasms
Locations
Kaiser Permanente Northern California
Oakland, California 94612
United States
AdventHealth
Orlando, Florida 32804
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States