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Chronic Radiation Induced Bowel Toxicity Study

NCT06640959 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-20

No results posted yet for this study

Summary

In the UK over 22,000 people undergo pelvic radiotherapy treatment per year, for several types of cancers including prostate cancer. The investigators want to investigate whether there are any differences in the bacteria in the bowel in patients with prostate cancer and whether these change during treatment.

The aim of this study is to analyse the bacteria from the stool of patients undergoing radiotherapy for prostate cancer. The investigators will also look for any changes in the urine, blood and using rectal swabs that might be a surrogate for what is happening in the gut at the same time. They will collect food frequency/ food diary information for each patient alongside health questionnaires.

The investigators aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period. Patients will be recruited across 2 sites (Rosemere Cancer Centre, Lancashire Teaching Hospitals Trust and The Christie NHS Foundation Trust).

Conditions

Interventions

PROCEDURE

Procedure - blood, urine and stool sample collection

Samples will be collected (blood, urine, stool and optional rectal swab) at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 weeks from start of radiotherapy, and at 6-month and 12-month follow-up appointments

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Lancashire Teaching Hospitals NHS Foundation Trust

    collaborator OTHER

  • The Christie NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640959 on ClinicalTrials.gov