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Colon PolypNCT07790718

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

A study testing Aerobic Exercise, Biopsy Procedure and Biospecimen Collection in people with Colon Polyp and Colorectal Carcinoma, run by City of Hope Medical Center at 2 sites in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years, men only
What is being tested?
Aerobic Exercise, Biopsy Procedure and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
16 Dec 2026to 12 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Gregory Idos, 626-228-4207, gidos@coh.org

    Gregory Idos

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Gregory Idos, 626-228-4207, gidos@coh.org

    Gregory Idos

    Recruiting

Other trials in United States

About this study

Official title: The Effects of Exercise on Colorectal Cancer Promotion Following Pelvic Radiotherapy for Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the effects of exercise on mitigating molecular features in collected normal mucosa sample and any polyps identified.

SECONDARY OBJECTIVES:

  1. Study longitudinal changes in predictors of colon cancer risk. II. Evaluate accrual and retention rates, as well as exercise compliance and safety.

EXPLORATORY OBJECTIVE:

  1. 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.

Being tested
Aerobic Exercise, Biopsy Procedure, Biospecimen Collection, Colonoscopy, Data Collection
Medical subject headings
Colonic Polyps, Colorectal Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseOther

    Also called Aerobic Activity

    Participate in individualized walking sessions

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood sample

  • ColonoscopyProcedure or surgery

    Undergo SOC colonoscopy

  • Data CollectionOther

    Undergo collection of Apple Health data

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • SigmoidoscopyProcedure or surgery

    Also called Proctosigmoidoscopy

    Undergo SOC flex sigmoidoscopy

  • Survey AdministrationOther

    Complete survey

Study groups in NCT07790718
Study groupRoleWhat they receive
Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)OtherPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Colonoscopy; Other: Data Collection; Procedure: Sigmoidoscopy; Other: Survey Administration
Stage 2 (individualized walking)ExperimentalPatients 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.
Receives: Other: Aerobic Exercise; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Colonoscopy; Other: Physical Performance Testing; Other: Questionnaire Administration; Procedure: Sigmoidoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)

  1. Blood-based biomarkers - blood immune-inflammatory profile

    Blood-based biomarkers - blood immune-inflammatory profile will be measured. 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.

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

  2. Blood-based biomarkers - ambient deoxyribonucleic acid damage

    Blood-based biomarkers - ambient deoxyribonucleic acid damage in circulating peripheral blood mononuclear cells will be measured. 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.

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

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

    Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid will be measured. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start16 Dec 2026 (estimated)
  3. Primary completion12 Jun 2027 (estimated)
  4. Study completion12 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07790718
Sponsor's protocol ID
25939
Other IDs
NCI-2026-05818, 25939, P30CA033572
Status last verified
Aug 2026
First submitted
17 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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