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

26. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • Rekruttering
        • City of Hope Medical Center
        • Hovedetterforsker:
          • Gregory Idos
        • Ta kontakt med:
      • Irvine, California, Forente stater, 92618
        • Rekruttering
        • City of Hope at Irvine Lennar
        • Hovedetterforsker:
          • Gregory Idos
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Annen: Undersøkelsesadministrasjon
Fullfør undersøkelsen
Fremgangsmåte: Koloskopi
Gjennomgå SOC koloskopi
Fremgangsmåte: Biopsiprosedyre
Gjennomgå biopsi
Andre navn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Annen: Data Collection
Undergo collection of Apple Health data
Fremgangsmåte: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andre navn:
  • Proktosigmoidoskopi
Eksperimentell: 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.
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Fremgangsmåte: Bioprøvesamling
Gjennomgå innsamling av blodprøve
Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Koloskopi
Gjennomgå SOC koloskopi
Annen: Fysisk ytelsestesting
Hjelpestudier
Andre navn:
  • Fysisk kondisjonstesting
  • Fysisk funksjonstesting
Fremgangsmåte: Biopsiprosedyre
Gjennomgå biopsi
Andre navn:
  • Bx
  • BIOPSY_TYPE
  • Biopsi
Fremgangsmåte: Sigmoidoscopy
Undergo SOC flex sigmoidoscopy
Andre navn:
  • Proktosigmoidoskopi
Annen: Aerobic Exercise
Participate in individualized walking sessions
Andre navn:
  • Aerobic aktivitet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Colon tissue molecular profiles - Whole genome sequencing
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood-based biomarkers - blood immune-inflammatory profile
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Gregory Idos, City of Hope Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

16. desember 2026

Primær fullføring (Antatt)

12. juni 2027

Studiet fullført (Antatt)

12. juni 2027

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25939 (Annen identifikator: City of Hope Comprehensive Cancer Center)
  • P30CA033572 (U.S. NIH-stipend/kontrakt)
  • NCI-2026-05818 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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