Exercise after pelvic radiation to see if it lowers colorectal cancer risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial enrolls men who had pelvic radiation for prostate cancer and checks if a structured aerobic walking program can modify molecular features associated with colorectal cancer in mucosal tissue and blood. Participants undergo initial colonoscopy or flexible sigmoidoscopy with biopsies, wear Apple Health data, and complete surveys. Those with low activity may advance to a 6-month program of supervised walking, 225 minutes per week, with follow-up tissue collection and safety assessments. An exploratory goal banks tissue for additional analyses to understand immune and mutational changes. The study also tracks feasibility metrics like recruitment, adherence, and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative

  * Assent, when appropriate, will be obtained per institutional guidelines
* Agreement to allow the use of archival tissue from diagnostic tumor biopsies

  * If unavailable, exceptions may be granted with study principal investigator (PI) approval
* Age: 40-80 years
* Body mass index (BMI): \> 25 kg/m\^2
* Has Apple Health application (app) on personal device with valid iOS operating software (i.e., iOS 15.0 or higher)
* Has a registered MyChart/MyCityofHope account (or be willing to register for one) and the app downloaded onto personal device
* Ability to read and understand English to review MyChart/MyCityofHope on-screen instructions to sync and share Apple Health data, and for safety during exercise testing
* Previously diagnosed with localized prostate cancer
* Completed pelvic radiotherapy 12-20 months ago
* Presence of abnormalities (e.g., polyps, lesions) in the colon
* Assessed for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (stage 2 only)
* Low physical activity, defined by \< 5,000 steps/day over the last 12 months as per Apple Health data (stage 2 only)

Exclusion Criteria:

* Enrollment in any other program (e.g., weight loss program) that may alter the impact of exercise on outcomes
* Presence of any other concurrent, actively treated malignancy
* Distant metastatic malignancy of any kind
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• City of Hope at Irvine Lennar
  Irvine, California, United States Recruiting

Study contacts

• Principal investigator: Gregory Idos — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.