NCT06640959Recruiting
Chronic Radiation Induced Bowel Toxicity Study
Chronic Radiation Induced Bowel Toxicity Study (CRIBS)
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 19 Nov 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- The Christie NHS Foundation Trust
- Diseases
- Prostate cancer
- NCT number
- NCT06640959
What you commit to
- Study type: Observational
- Planned participants: 50
- From 19 Nov 2024 to the primary completion date, Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had received systemic antibiotics (intravenous, intramuscular, or oral) within 2 months before enrolment.
- Had received cytotoxic or immunosuppressive therapies within 6 months of enrolment, including chemotherapy or immunotherapy.
- Patients with previous colorectal cancer
Other illness
- Patients with diagnosed inflammatory bowel disease or coeliac disease
- Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)
Other
- Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of enrolment (such as Actimint®, CranProBio®, ImmunoProBio®, among others).
- Patients who have undergone colectomy (total or subtotal)
Who the study is looking for
- Male, aged ≥ 18; no upper age limit and able to give informed consent.
- Newly diagnosed patients with, histologically confirmed, localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0).
- Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen.
- Performance status - ECOG 0-2.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Lancashire Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Preston | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.