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Clinical Trials/NCT05789433
NCT05789433
Recruiting
Not Applicable

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

AdventHealth Translational Research Institute1 site in 1 country70 target enrollmentMay 1, 2023

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
March 1, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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