Testing the Effects of Exercise on Colorectal Cancer Development After Treatment With Pelvic Radiation Therapy for Prostate Cancer

Conditions

• Colon Polyp
• Colorectal Carcinoma
• Localized Prostate Carcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex

MALE

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Aerobic Exercise — OTHER
  Participate in individualized walking sessions
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo collection of blood sample
• Colonoscopy — PROCEDURE
  Undergo SOC colonoscopy
• Data Collection — OTHER
  Undergo collection of Apple Health data
• Physical Performance Testing — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies
• Sigmoidoscopy — PROCEDURE
  Undergo SOC flex sigmoidoscopy
• Survey Administration — OTHER
  Complete survey

Study Details

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.

Key Dates

First listed

Aug 27, 2026

Start date

Dec 16, 2026

Status verified

Aug 2026

Primary completion

Jun 12, 2027

Completion

Jun 12, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Arms

• Other: Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)
  Patients undergo 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.
• Experimental: Stage 2 (individualized walking)
  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.

Primary Outcome Measure

Colon tissue molecular profiles - Whole genome sequencing [ Time Frame: From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) ]

Locations (2)

Find similar trials in Duarte, CA

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