Chronic Radiation Induced Bowel Toxicity Study (CRIBS)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Christie NHS Foundation Trust
RECRUITING
Manchester
Lancashire Teaching Hospitals NHS Foundation Trust
RECRUITING
Preston
Contact Information
Primary
Lois Gardner, PhD
lois.gardner@manchester.ac.uk
01612008863
Backup
Eleanor Cheadle, PhD
eleanor.j.cheadle@manchester.ac.uk
01612008863
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2027-07
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Collaborators: University of Manchester, Lancashire Teaching Hospitals NHS Foundation Trust
Leads: The Christie NHS Foundation Trust

This content was sourced from clinicaltrials.gov