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Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

RECRUITINGN/ASponsored by AdventHealth Translational Research Institute
Actively Recruiting
PhaseN/A
SponsorAdventHealth Translational Research Institute
Started2023-06-01
Est. completion2027-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerColonic Neoplasms

Locations3 sites

California

1 site
Kaiser Permanente Northern California
Oakland, California, 94612

Florida

1 site
AdventHealth
Orlando, Florida, 32804

Massachusetts

1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christine Lu, M.P.H.christine_lu@dfci.harvard.edu

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