RecruitingNot ApplicableNCT05773144

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer


Sponsor

AdventHealth Translational Research Institute

Enrollment

219 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria12

  • 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 Criteria6

  • 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

Interventions

BEHAVIORALAerobic exercise

Moderate- to vigorous-intensity aerobic exercise

BEHAVIORALProgressive stretching

Static stretching of eight major muscle groups


Locations(3)

Kaiser Permanente Northern California

Oakland, California, United States

AdventHealth

Orlando, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT05773144


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