Aerobic exercise during chemotherapy for colon cancer patients

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

This study is testing if doing aerobic exercise during chemotherapy can help people with stage II or III colon cancer get better results from their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 219 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AdventHealth Translational Research Institute (other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Oakland, California and 2 other locations)
• Trial ID: NCT05773144 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effects of aerobic exercise training on chemotherapy dose intensity in survivors of stage II or III colon cancer. Participants will be randomized to either an aerobic exercise program or an attention control group to assess the dose-response relationship. The study will include adults who have completed surgical resection and are about to begin chemotherapy, ensuring they meet specific health criteria. The goal is to determine if exercise can enhance the effectiveness of chemotherapy in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage II or III colon cancer who have completed surgery and are about to start chemotherapy.

Not a fit: Patients with metastatic colon cancer or those currently undergoing treatment for other cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve chemotherapy outcomes and overall health for colon cancer survivors through structured aerobic exercise.

How similar studies have performed: Other studies have shown positive outcomes with exercise interventions during cancer treatment, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Oakland, California and 2 other locations

• Kaiser Permanente Northern California — Oakland, California, United States (RECRUITING)
• AdventHealth — Orlando, Florida, United States (RECRUITING)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Justin C. Brown, Ph.D. — AdventHealth
• Study coordinator: Justin C. Brown, Ph.D.

Conditions: Colonic Neoplasms