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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
NCT05773144 · AdventHealth Translational Research Institute
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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 design
Enrollment target: 219 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-06-01
Estimated completion: 2027-05-01
Last updated: 2026-01-07
Interventions
Behavioral: Aerobic exerciseBehavioral: Progressive stretching
Primary outcomes
- • Chemotherapy Relative Dose Intensity (12- or 24-weeks)
Sponsor
AdventHealth Translational Research Institute · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactJustin C. Brown, Ph.D. · contact · Justin.Brown4@AdventHealth.com · 4076095000
InvestigatorJustin C. Brown, Ph.D. · principal_investigator, AdventHealth
InvestigatorJeffrey A. Meyerhardt, M.D., M.P.H. · principal_investigator, Dana-Farber Cancer Institute
InvestigatorBette J. Caan, Dr.P.H. · principal_investigator, Kaiser Permanente
All locations (3)
Kaiser Permanente Northern CaliforniaRecruiting
Oakland, California, United States
AdventHealthRecruiting
Orlando, Florida, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States