Chronic Radiation Induced Bowel Toxicity Study

Launched by THE CHRISTIE NHS FOUNDATION TRUST · Oct 10, 2024

Keywords

ClinConnect Summary

The Chronic Radiation Induced Bowel Toxicity Study is looking into how the bacteria in the bowel of men with prostate cancer may change during their treatment with pelvic radiotherapy. Each year, over 22,000 people in the UK receive this type of treatment for various cancers, including prostate cancer. Researchers want to understand if these changes in bacteria can help us learn more about the patient's health during treatment. They will collect samples from patients' stools, urine, blood, and rectal swabs, along with information about their diets and health through questionnaires.

To participate in this study, you need to be a male aged 18 or older who has been newly diagnosed with localized prostate cancer that is classified as intermediate to high-risk. You should be scheduled to receive a specific type of radiotherapy called IMRT. However, if you have recently taken certain medications or have specific health conditions, you might not be eligible. The study is recruiting about 50 patients over two years from two hospitals in the UK. If you join, you can expect to provide samples and information about your health and diet throughout your treatment. Your involvement could help improve our understanding of how radiotherapy affects the gut and overall health in prostate cancer patients.

Gender

MALE

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)