NCT06640959 Chronic Radiation Induced Bowel Toxicity Study
| NCT ID | NCT06640959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Christie NHS Foundation Trust |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-11-19 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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 with diagnosed inflammatory bowel disease or coeliac disease * Patients with previous colorectal cancer * Patients who have undergone colectomy (total or subtotal) * Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06640959 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06640959 currently recruiting?
Yes, NCT06640959 is actively recruiting participants. Contact the research team at lois.gardner@manchester.ac.uk for enrollment information.
Where is the NCT06640959 trial being conducted?
This trial is being conducted at Manchester, United Kingdom, Preston, United Kingdom.
Who is sponsoring the NCT06640959 clinical trial?
NCT06640959 is sponsored by The Christie NHS Foundation Trust. The trial plans to enroll 50 participants.
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