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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
NCT ID: NCT05773144Sponsor: AdventHealth Translational Research InstituteLast updated: 2026-01-07
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.
Arms & interventions
- BehavioralAerobic exercise
Moderate- to vigorous-intensity aerobic exercise
- BehavioralProgressive stretching
Static stretching of eight major muscle groups
Outcome measures
Primary
Chemotherapy Relative Dose Intensity
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Time frame: 12- or 24-weeks
Eligibility criteria
Sex: AllAge: 18 Years and olderHealthy volunteers: No
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
Study locations (3)
Kaiser Permanente Northern California
Oakland, California, 94612
Bette J Caan, Dr.P.H. · Principal Investigator
AdventHealth
Orlando, Florida, 32804
Justin Brown, Ph.D. · Principal Investigator
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Jeffrey A Meyerhardt, M.D. · Principal Investigator