Actively Recruiting
Chronic Radiation Induced Bowel Toxicity Study (CRIBS) Investigating Bowel Bacteria Changes During Radiotherapy for Prostate Cancer An Observational Study by The Christie NHS Foundation Trust
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
Researchers are studying the bacteria in the bowel of patients with prostate cancer who are undergoing pelvic radiotherapy. This research aims to understand the immunological changes caused by radiation in the bowel mucosa, blood, and urine, and to explore how the microbiota may influence bowel toxicity during and after treatment. The study plans to include about 50 male patients diagnosed with localized intermediate to high-risk prostate cancer who will receive standard radical radiotherapy. Participants will provide stool, blood, urine, and optional rectal swab samples before starting radiotherapy, weekly during the 4-week treatment, at 6-8 weeks and 12 weeks after starting treatment, and at 6-month and 12-month follow-ups. They will also complete food diaries and health questionnaires during these times. The radiotherapy regimen involves intensity modulated radiotherapy (IMRT) with a total dose of 60Gy over 20 fractions. Throughout the study, patients' samples will be collected and analyzed to track changes in bacteria and immune responses over time. Researchers will monitor quality of life through questionnaires and diet diaries. The main goal is to assess the feasibility of obtaining these repeated biological samples for up to 12 months after treatment to better understand bowel toxicity related to radiotherapy.
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
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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
E
Eleanor Cheadle, PhD
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
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