Testing the Effects of Exercise on Colorectal Cancer Development After Treatment With Pelvic Radiation Therapy for Prostate Cancer
Start Date
12/16/2026
Completion Date
6/12/2027
Summary
This clinical trial evaluates the effects of exercise therapy on signs of colorectal cancer in colon tissue and blood in people who completed pelvic radiation therapy for prostate cancer. People who get radiation in the pelvic area have a higher chance of developing colon cancer years later. This is because radiation can cause new mutations and inflammation. Research shows that exercise lowers colon cancer risk by about 30%. The results of this trial may help researchers better understand how exercise affects the development of colorectal cancer in patients who were treated with pelvic radiation therapy for prostate cancer.
Detailed Description
PRIMARY OBJECTIVE: I. Determine the effects of exercise on mitigating molecular features in collected normal mucosa sample and any polyps identified. SECONDARY OBJECTIVES: I. Study longitudinal changes in predictors of colon cancer risk. II. Evaluate accrual and retention rates, as well as exercise compliance and safety. EXPLORATORY OBJECTIVE: I. Bank tissue from standard of care colonoscopies/flex sigmoidoscopies for exploratory biological analyses (e.g., immune cell infiltration, mutational signature analysis). OUTLINE: STAGE 1: Patients undergo standard of care (SOC) colonoscopy/flex sigmoidoscopy with tissue biopsy, have their Apple Health physical activity data collected and analyzed, and complete a survey. Patients determined to have low physical activity over the previous 12 months may proceed to Stage 2. STAGE 2: Patients participate in individualized walking sessions over 10-70 minutes each, 5 times per week (225 minutes total per week), for 6 months. Patients also undergo collection of a blood sample on study and undergo SOC colonoscopy/flex sigmoidoscopy with tissue biopsy during follow-up. After completion of study intervention, patients are followed up within 2 weeks, or up to 3 months, for completion of follow-up SOC colonoscopy/flex sigmoidoscopy.
Eligibility Criteria
Age Range: 40 years to 80 years
Interventions
Aerobic Exercise
Biopsy Procedure
Biospecimen Collection
Colonoscopy
Data Collection
Physical Performance Testing
Questionnaire Administration
Sigmoidoscopy
Survey Administration
Conditions
Locations
City of Hope Medical Center
Duarte, California 91010
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States