NCT05789433
Recruiting
Not Applicable
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Neoplasms
- Sponsor
- AdventHealth Translational Research Institute
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Whole-Body Intermuscular Adipose Tissue
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.
Investigators
Justin Brown
Director, Exercise & Cancer Biology Research Program
AdventHealth Translational Research Institute
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •Histologically confirmed stage I, II, or III colon or rectal cancer
- •Completed surgical resection with curative intent
- •Completed other cancer-directed treatments
- •Engage in \<150 minutes per week of moderate- to vigorous-intensity structured endurance exercise
- •No planned major surgery during the study period
- •Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
- •Ability to provide written informed consent
- •Provide written approval by a qualified healthcare professional
- •Willing to be randomized
Exclusion Criteria
- •Evidence of metastatic or recurrent colorectal cancer
- •Concurrently actively treated other (non-colorectal) cancer
- •Scheduled to receive other postoperative cancer-directed treatment(s)
- •Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
- •Currently participating in another study with competing outcomes
- •Contraindications to magnetic resonance imaging
- •Any dietary condition or restriction that would limit tolerance of a mixed meal challenge
- •Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, 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
Outcomes
Primary Outcomes
Whole-Body Intermuscular Adipose Tissue
Time Frame: up to Week 12
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
Study Sites (1)
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