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

NCT07790718 | Recruiting

• 3 other identifiers: 25939NCI-2026-05818P30CA033572
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Colon tissue molecular profiles - Whole genome sequencing

  Whole genome sequencing will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.

  From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)

• Colon tissue molecular profiles - Single-cell ribonucleic acid sequencing

  Single-cell ribonucleic acid sequencing will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.

  From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)

• Colon tissue molecular profiles - Associated molecular assays

  Associated molecular assays will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.

  From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)

Secondary Outcomes (3)

• Blood-based biomarkers - blood immune-inflammatory profile

  From baseline to 6 months post-intervention (up to 6 months)

• Blood-based biomarkers - ambient deoxyribonucleic acid damage

  From baseline to 6 months post-intervention (up to 6 months)

• Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid

  From baseline to 6 months post-intervention (up to 6 months)

Study Arms (2)

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)

OTHER

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.

Procedure: Biopsy Procedure; Procedure: Colonoscopy; Other: Data Collection; Procedure: Sigmoidoscopy; Other: Survey Administration

Stage 2 (individualized walking)

EXPERIMENTAL

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.

Other: Aerobic Exercise; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Colonoscopy; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Sigmoidoscopy

Interventions

Aerobic Exercise OTHER

Participate in individualized walking sessions

Also known as: Aerobic Activity

Stage 2 (individualized walking)

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data); Stage 2 (individualized walking)

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Stage 2 (individualized walking)

Colonoscopy PROCEDURE

Undergo SOC colonoscopy

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data); Stage 2 (individualized walking)

Data Collection OTHER

Undergo collection of Apple Health data

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Stage 2 (individualized walking)

Questionnaire Administration OTHER

Ancillary studies

Stage 2 (individualized walking)

Sigmoidoscopy PROCEDURE

Undergo SOC flex sigmoidoscopy

Also known as: Proctosigmoidoscopy

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data); Stage 2 (individualized walking)

Survey Administration OTHER

Complete survey

Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms; Prostatic Neoplasms

Interventions

Exercise; Biopsy; Specimen Handling; Colonoscopy; Data Collection; Exercise Test; Sigmoidoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Study Officials

• Gregory Idos

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): December 16, 2026
• Primary Completion (Estimated): June 12, 2027
• Study Completion (Estimated): June 12, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (2)