Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how aerobic exercise during chemotherapy affects patients with colon cancer. Researchers want to see if doing regular aerobic exercise—like walking, jogging, or swimming—can help improve the effectiveness of chemotherapy for people who have had surgery for stage II or III colon cancer. The trial will compare the exercise group with a control group that receives regular attention and support without the exercise component.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of stage II or III colon cancer, and be planning to start chemotherapy soon. They should not be exercising more than 60 minutes a week at a moderate to vigorous level before joining. Participants will need to be able to walk 400 meters and communicate in English. It’s important to note that those with more advanced cancer, other active cancers, or certain health issues may not qualify. If chosen, participants can expect to engage in an exercise program while receiving support and monitoring throughout their chemotherapy treatment.

Gender

ALL

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