Chronic Radiation Induced Bowel Toxicity Study
Recruiting · NCT06640959 · Observational (researchers observe without assigning treatment) · Lead sponsor: The Christie NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
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)
Where it is running
2 locations listed.
- Christie NHS Foundation Trust - Manchester, Greater Manchester, United Kingdom
- Lancashire Teaching Hospitals NHS Foundation Trust - Preston, Lancashire, United Kingdom