An interventional study of Aerobic Exercise and Biopsy Procedure in Colon Polyp, Colorectal Carcinoma and Localized Prostate Carcinoma, sponsored by City of Hope Medical Center. Recruiting at 2 sites in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 30 is below the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented of the participant and/or legally authorized representative
Agreement to allow the use of from diagnostic tumor biopsies
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participate in individualized walking sessions
Also known as: Aerobic Activity
Undergo biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo collection of blood sample
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo SOC colonoscopy
Undergo collection of Apple Health data
Ancillary studies
Also known as: Physical Fitness Testing, Physical Function Testing
Ancillary studies
Undergo SOC flex sigmoidoscopy
Also known as: Proctosigmoidoscopy
Complete survey
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.
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
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.
Time frame: 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.
Time frame: From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)
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.
Time frame: From baseline to 6 months post-intervention (up to 6 months)
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.
Time frame: From baseline to 6 months post-intervention (up to 6 months)
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.
Time frame: From baseline to 6 months post-intervention (up to 6 months)
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