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NCT Number: NCT05773144

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

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.

Recruiting

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Moderate- to vigorous-intensity aerobic exercise

Progressive Stretching

Behavioral

Static stretching of eight major muscle groups

Primary outcomes

  1. Chemotherapy Relative Dose Intensity

    Time frame: 12- or 24-weeks

    The ratio of the delivered dose intensity to the standard or planned dose intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin C. Brown, Ph.D.

CONTACT

[email protected]

4076095000

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: ACTION

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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