Actively Recruiting
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Led by AdventHealth Translational Research Institute · Updated on 2026-01-07
219
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AdventHealth Translational Research Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how different amounts of aerobic exercise during chemotherapy affect the chemotherapy dose intensity in people who have survived colon cancer. The study focuses on adults with confirmed stage II or III colon cancer who have completed surgery and are starting chemotherapy. The goal is to understand the relationship between exercise dose and chemotherapy delivery among colon cancer survivors. Participants are randomly assigned to one of five groups: a control group performing static stretching or one of four aerobic exercise groups with increasing weekly durations of 75, 150, 225, or 300 minutes. The aerobic exercise involves moderate- to vigorous-intensity activity. The study uses adaptive randomization with double masking to compare these different exercise doses against attention control during the chemotherapy period. During the study, participants will be monitored for their chemotherapy relative dose intensity over 12 or 24 weeks. Researchers will assess physical ability, exercise readiness, and collect consent and healthcare professional approvals before participation. The study tracks adherence to exercise prescriptions and evaluates safety and compliance throughout the intervention period. Total participation time corresponds with chemotherapy treatment duration and study assessments.
CONDITIONS
Brief Title
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed stage II or III colon cancer
- Completed surgical resection with curative intent
- Plan to initiate chemotherapy
- Engages in less than 60 minutes per week of moderate to vigorous aerobic exercise
- No planned major surgery during the study period
- Ready to exercise as determined by a modified Physical Activity Readiness Questionnaire
- Able to walk 400 meters
- Can read and speak English
- Able to provide written informed consent
- Provides written approval by a qualified healthcare professional
- Willing to be randomized
You will not qualify if you...
- Evidence of metastatic colon cancer
- Actively treated other (non-colon) cancer concurrently
- Currently pregnant, breastfeeding, or planning pregnancy within 24 weeks
- Participating in another study with competing outcomes
- Any condition that may prevent participation or successful compliance as judged by the investigator
- Any situation negatively impacting safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 24 weeks
Participants engage in assigned aerobic exercise or static stretching during chemotherapy treatment.
Weekly visits to monitor exercise adherence and safety
Trial Site Locations
Total: 3 locations
1
Kaiser Permanente Northern California
Oakland, California, United States, 94612
Actively Recruiting
2
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Justin C. Brown, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here