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

ConditionsColon PolypColorectal CarcinomaLocalized Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Aerobic Exercise

    Other intervention

    Participate in individualized walking sessions

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood sample

  • Colonoscopy

    Procedure/Surgery

    Undergo SOC colonoscopy

  • Data Collection

    Other intervention

    Undergo collection of Apple Health data

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Sigmoidoscopy

    Procedure/Surgery

    Undergo SOC flex sigmoidoscopy

  • Survey Administration

    Other intervention

    Complete survey

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)Other 5 interventions
Group B: Stage 2 (individualized walking)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
From baseline to 6 months post-intervention (up to 6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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