RecruitingNCT06640959

Chronic Radiation Induced Bowel Toxicity Study

Chronic Radiation Induced Bowel Toxicity Study (CRIBS)


Sponsor

The Christie NHS Foundation Trust

Enrollment

50 participants

Start Date

Nov 19, 2024

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how radiation treatment for prostate cancer affects the bowel over time, and whether factors like gut bacteria play a role in the severity of bowel side effects. **You may be eligible if...** - You are male and at least 18 years old - You have been newly diagnosed with intermediate to high-risk prostate cancer confined to the prostate - You are scheduled to receive a specific type of radiation treatment (IMRT, 60 Gy in 20 treatments) - Your general health is reasonably good **You may NOT be eligible if...** - You have taken antibiotics in the past 2 months - You have had chemotherapy or immunosuppressive therapy in the past 6 months - You have taken high-dose commercial probiotics in the past 12 months - You have inflammatory bowel disease, celiac disease, or a history of colorectal cancer - You have had part or all of your colon removed - You have a history of diverticulitis (inflamed pouches in the colon) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProcedure - 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


Locations(2)

Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, United Kingdom

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NCT06640959


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