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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

NCT05773144 · AdventHealth Translational Research Institute
In plain English

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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
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer · TrialPath