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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 3 months
  • Procedures mentioned: Biopsies, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how exercise affects signs of colorectal cancer (cancer of the colon or rectum) in colon tissue and blood. It is for people who finished pelvic radiation for prostate cancer 12–20 months ago and have changes in their colon, such as polyps or other abnormal areas.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40–80 years old and have a body mass index (BMI), a measure of weight compared with height, above 25.
  • Have had localized prostate cancer (cancer that had not spread far) and finished pelvic radiation 12–20 months ago.
  • Have polyps (growths) or other abnormal areas in the colon.
  • You or your legal representative must give written consent. Allow use of stored tissue from earlier tumor tests, unless the study leader approves an exception because tissue is not available.
  • Have Apple Health on your own device with iOS 15.0 or newer.
  • Have a MyChart/MyCityofHope account, or agree to create one, and download the app onto your device.
  • Be able to read and understand English for app instructions, sharing Apple Health data, and safe exercise testing.
  • For stage 2 only: pass an exercise readiness screening and have fewer than 5,000 steps a day over the past 12 months, based on Apple Health data.

Who can't join

  • Be in another program, such as a weight-loss program, that could affect the study's exercise results.
  • Have another cancer that is being actively treated.
  • Have any cancer that has spread to distant parts of the body.
  • Have a condition that the study doctor thinks would make study procedures unsafe.
  • The study doctor thinks you may not be able to follow all study steps, including because of practical or scheduling problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

CA