Recruiting

Aerobic Exercise

Sponsor:

AdventHealth Translational Research Institute

Code:

NCT05773144

Conditions

Colonic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aerobic exercise

Progressive stretching

Study Details

Brief 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.

Conditions

Colonic Neoplasms

Study ID

NCT05773144

Start date

Jun 1, 2023

Status verified date

Jan, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

219 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

sham comparator: Attention control

Static stretching

experimental: 75 min/wk aerobic exercise

Aerobic exercise at a dose of 75 minutes per week

experimental: 150 min/wk aerobic exercise

Aerobic exercise at a dose of 150 minutes per week

experimental: 225 min/wk aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

experimental: 300 min/wk aerobic exercise

Aerobic exercise at a dose of 300 minutes per week

Interventions

Aerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Progressive stretching

Static stretching of eight major muscle groups

Primary outcome measure

  • Chemotherapy Relative Dose Intensity [ Time Frame: 12- or 24-weeks ]

Central Contacts and Locations

Central contacts

Justin C. Brown, Ph.D.

4076095000Justin.Brown4@AdventHealth.com

Locations

Kaiser Permanente Northern California

Recruiting

Oakland, California, United States, 94612

Contacts

Michelle Ross

Michelle.C.Ross@kp.org

Principal Investigator:

Bette J Caan, Dr.P.H.

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Abigail Tice, Ph.D.

Abigail.Tice@AdventHealth.com

Principal Investigator:

Justin Brown, Ph.D.

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christine Lu, M.P.H.

christine_lu@dfci.harvard.edu

Principal Investigator:

Jeffrey A Meyerhardt, M.D.

More Information

Sponsor

AdventHealth Translational Research Institute

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth Translational Research Institute on 2026-01-07.