Actively Recruiting
Chronic Radiation Induced Bowel Toxicity Study
Led by The Christie NHS Foundation Trust · Updated on 2024-12-20
50
Participants Needed
2
Research Sites
136 weeks
Total Duration
On this page
Sponsors
T
The Christie NHS Foundation Trust
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Chronic Radiation Induced Bowel Toxicity Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, aged 18 or older, able to give informed consent
- Newly diagnosed with histologically confirmed localized, intermediate to high-risk prostate cancer (T2b-T4a N0 M0)
- Planned treatment with prostate radical radiotherapy IMRT (60Gy in 20 fractions over 4 weeks) with curative intent
- Performance status ECOG 0-2
You will not qualify if you...
- Received systemic antibiotics within 2 months before enrollment
- Received cytotoxic or immunosuppressive therapies including chemotherapy or immunotherapy within 6 months before enrollment
- Consumed large doses of commercial probiotics (≥108 CFU per day) within 12 months before enrollment
- Diagnosed with inflammatory bowel disease or coeliac disease
- Previous colorectal cancer
- Previous total or subtotal colectomy
- History of diverticulitis (uncomplicated diverticular disease allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
2
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Lancashire, United Kingdom, PR2 9HT
Actively Recruiting
Research Team
L
Lois Gardner, PhD
CONTACT
E
Eleanor Cheadle, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here