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
Conditions
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.
Detailed description
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.
Interventions
OTHERAerobic Exercise
Participate in individualized walking sessions
PROCEDUREBiopsy Procedure
Undergo biopsy
PROCEDUREBiospecimen Collection
Undergo collection of blood sample
PROCEDUREColonoscopy
Undergo SOC colonoscopy
OTHERData Collection
Undergo collection of Apple Health data
OTHERPhysical Performance Testing
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESigmoidoscopy
Undergo SOC flex sigmoidoscopy
OTHERSurvey Administration
Complete survey
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colon tissue molecular profiles - Whole genome sequencing | From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) | 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. |
| Colon tissue molecular profiles - Single-cell ribonucleic acid sequencing | From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) | 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. |
| Colon tissue molecular profiles - Associated molecular assays | From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood-based biomarkers - blood immune-inflammatory profile | From baseline to 6 months post-intervention (up to 6 months) | 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. |
| Blood-based biomarkers - ambient deoxyribonucleic acid damage | From baseline to 6 months post-intervention (up to 6 months) | 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. |
| Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid | From baseline to 6 months post-intervention (up to 6 months) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregory Idos
City of Hope Medical Center
Outcome results
None listed