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

26 augustus 2026 bijgewerkt door: City of Hope Medical Center

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Duarte, California, Verenigde Staten, 91010
        • Werving
        • City of Hope Medical Center
        • Hoofdonderzoeker:
          • Gregory Idos
        • Contact:
          • Gregory Idos
          • Telefoonnummer: 626-228-4207
          • E-mail: gidos@coh.org
      • Irvine, California, Verenigde Staten, 92618
        • Werving
        • City of Hope at Irvine Lennar
        • Hoofdonderzoeker:
          • Gregory Idos
        • Contact:
          • Gregory Idos
          • Telefoonnummer: 626-228-4207
          • E-mail: gidos@coh.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Stage 1 (coloscopy/sigmoidoscopy, biopsy, health data)
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.
Ander: Enquête Administratie
Volledige enquête
Procedure: Colonoscopie
SOC colonoscopie ondergaan
Procedure: Biopsieprocedure
Ondergaan biopsie
Andere namen:
  • Bx
  • BIOSY_TYPE
  • Biopsie
Ander: Data Collection
Undergo collection of Apple Health data
Procedure: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andere namen:
  • Proctosigmoidoscopie
Experimenteel: Stage 2 (individualized walking)
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.
Ander: Vragenlijst administratie
Nevenstudies
Procedure: Biospecimen-collectie
Onderga bloedafname
Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Colonoscopie
SOC colonoscopie ondergaan
Ander: Fysieke prestatietests
Aanvullende studies
Andere namen:
  • Fysieke fitheid testen
  • Fysieke functie testen
Procedure: Biopsieprocedure
Ondergaan biopsie
Andere namen:
  • Bx
  • BIOSY_TYPE
  • Biopsie
Procedure: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andere namen:
  • Proctosigmoidoscopie
Ander: Aerobic Exercise
Participate in individualized walking sessions
Andere namen:
  • Aërobe Activiteit

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Colon tissue molecular profiles - Whole genome sequencing
Tijdsspanne: 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.
From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)
Colon tissue molecular profiles - Single-cell ribonucleic acid sequencing
Tijdsspanne: 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.
From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)
Colon tissue molecular profiles - Associated molecular assays
Tijdsspanne: 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.
From baseline up to completion of follow-up colonoscopy/flex sigmoidoscopy (up to 3 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood-based biomarkers - blood immune-inflammatory profile
Tijdsspanne: 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.
From baseline to 6 months post-intervention (up to 6 months)
Blood-based biomarkers - ambient deoxyribonucleic acid damage
Tijdsspanne: 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.
From baseline to 6 months post-intervention (up to 6 months)
Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid
Tijdsspanne: 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.
From baseline to 6 months post-intervention (up to 6 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

City of Hope Medical Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Gregory Idos, City of Hope Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

16 december 2026

Primaire voltooiing (Geschat)

12 juni 2027

Studie voltooiing (Geschat)

12 juni 2027

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

27 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25939 (Andere identificatie: City of Hope Comprehensive Cancer Center)
  • P30CA033572 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2026-05818 (Register-ID: CTRP (Clinical Trial Reporting Program))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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