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RecruitingInterventional

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

Recruiting
Michelle Ross · Contact
Bette J Caan, Dr.P.H. · Principal Investigator

AdventHealth

Orlando, Florida, 32804

Recruiting
Abigail Tice, Ph.D. · Contact
Justin Brown, Ph.D. · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Christine Lu, M.P.H. · Contact
Jeffrey A Meyerhardt, M.D. · Principal Investigator