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

26 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • Rekrytering
        • City of Hope Medical Center
        • Huvudutredare:
          • Gregory Idos
        • Kontakt:
      • Irvine, California, Förenta staterna, 92618
        • Rekrytering
        • City of Hope at Irvine Lennar
        • Huvudutredare:
          • Gregory Idos
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Övrig: Undersökningsadministration
Fyll i enkäten
Procedur: Koloskopi
Genomgå SOC koloskopi
Procedur: Biopsiförfarande
Genomgå biopsi
Andra namn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Övrig: Data Collection
Undergo collection of Apple Health data
Procedur: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andra namn:
  • Proktosigmoidoskopi
Experimentell: 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.
Övrig: Enkätadministration
Sidostudier
Procedur: Bioprovsamling
Genomgå insamling av blodprov
Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Procedur: Koloskopi
Genomgå SOC koloskopi
Övrig: Fysisk prestationstestning
Sidostudier
Andra namn:
  • Fysisk konditionstestning
  • Fysisk funktionstestning
Procedur: Biopsiförfarande
Genomgå biopsi
Andra namn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Procedur: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andra namn:
  • Proktosigmoidoskopi
Övrig: Aerobic Exercise
Participate in individualized walking sessions
Andra namn:
  • Aerob aktivitet

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Colon tissue molecular profiles - Whole genome sequencing
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood-based biomarkers - blood immune-inflammatory profile
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Gregory Idos, City of Hope Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

16 december 2026

Primärt slutförande (Beräknad)

12 juni 2027

Avslutad studie (Beräknad)

12 juni 2027

Studieregistreringsdatum

Först inskickad

17 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2026

Första postat (Faktisk)

27 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25939 (Annan identifierare: City of Hope Comprehensive Cancer Center)
  • P30CA033572 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2026-05818 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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