Chronic Radiation Induced Bowel Toxicity Study

NCT06640959 | Recruiting

• 1 other identifier: CFTsp225
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Prostate Cancer

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of obtaining longitudinal blood, urine and stool samples

  Feasibility of obtaining longitudinal blood, urine and stool samples from patients with newly diagnosed prostate cancer undergoing standard of care radiotherapy. Samples will be collected at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 from the start of radiotherapy, and at 6-month and 12-month follow-up appointments.

  From enrolment until 12 months post treatment

Interventions

Procedure - blood, urine and stool sample collection PROCEDURE

Samples will be collected (blood, urine, stool and optional rectal swab) at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 weeks from start of radiotherapy, and at 6-month and 12-month follow-up appointments

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients with prostate cancer

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Manchester: collaborator
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

RECRUITING

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, blood samples, mid-stream urine samples, optional rectal swab samples

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Urination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Lois Gardner, PhD

CONTACT

01612008863; lois.gardner@manchester.ac.uk

Eleanor Cheadle, PhD

CONTACT

01612008863; eleanor.j.cheadle@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)