Recruiting

Exercise Therapy

Sponsor:

City of Hope Medical Center

Code:

NCT07790718

Conditions

Colon Polyp

Colorectal Carcinoma

Localized Prostate Carcinoma

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Aerobic Exercise

Biopsy Procedure

Biospecimen Collection

Colonoscopy

Data Collection

Study Details

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

Study ID

NCT07790718

Start date

Dec 16, 2026

Status verified date

Aug, 2026

Completion date

Jun 12, 2027

Anticipated

Primary completion date

Jun 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Aerobic Exercise

Participate in individualized walking sessions

Biopsy Procedure

Undergo biopsy

Biospecimen Collection

Undergo collection of blood sample

Colonoscopy

Undergo SOC colonoscopy

Data Collection

Undergo collection of Apple Health data

Physical Performance Testing

Ancillary studies

Questionnaire Administration

Ancillary studies

Sigmoidoscopy

Undergo SOC flex sigmoidoscopy

Survey Administration

Complete survey

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) ]
  • Colon tissue molecular profiles - Single-cell ribonucleic acid sequencing [ Time Frame: From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) ]
  • Colon tissue molecular profiles - Associated molecular assays [ Time Frame: From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Gregory Idos

626-228-4207gidos@coh.org

Principal Investigator:

Gregory Idos

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Gregory Idos

626-228-4207gidos@coh.org

Principal Investigator:

Gregory Idos

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-28.