RecruitingOBSERVATIONAL

Chronic Radiation Induced Bowel Toxicity Study

This study is for men with prostate cancer who are having radiotherapy. Each year, many people in the UK get radiotherapy for cancers in the tummy area, including prostate cancer. We want to understand if the friendly germs (bacteria) in your gut change during this treatment. We'll collect samples of your poo, pee, and blood, and ask you about what you eat. This will help us learn if changes in gut bacteria are linked to any tummy side effects from radiotherapy. By doing this, we hope to improve care for future patients. About 50 men will take part from two hospitals in Lancashire and Manchester.

At a glance

Status

Recruiting

Sponsor

The Christie NHS Foundation Trust

Enrolment target

Start

19 Nov 2024

Estimated completion

01 Jul 2027

Prostate Cancer

What is this study about?

This study is for men with prostate cancer who are going to have radiotherapy as part of their treatment. Radiotherapy is a common and effective treatment, but it can sometimes cause tummy problems, both during treatment and afterwards. Researchers believe that the helpful germs (bacteria) that live in our gut, known as the gut microbiome, might play a role in why some people have these side effects and others don't.

The main goal of this study is to look closely at these gut bacteria. We want to see if they change during and after radiotherapy for prostate cancer. We'll also be looking at changes in your blood and pee, and collecting information about your diet. This will help us build a full picture of what's happening in your body and see if there's a link between your gut bacteria, your diet, and any tummy side effects you might experience.

By understanding these changes better, doctors hope to find ways to reduce or prevent tummy problems for men having radiotherapy for prostate cancer in the future. This could lead to better comfort and quality of life for patients. Around 50 men will be asked to join this study over two years, from two different hospitals.

Key takeaways

This study aims to understand how radiotherapy affects gut bacteria in men with prostate cancer.
It involves providing samples like poo, pee, and blood at different times.
You'll also complete food diaries and health questionnaires.
The study lasts about 12 months in total.
Your participation helps improve care for future patients.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for men aged 18 or over who have been recently diagnosed with prostate cancer that is considered intermediate to high-risk. You must be planning to have a specific type of radiotherapy treatment called IMRT (Intensity Modulated Radiotherapy) for your prostate cancer, which is given over 4 weeks with the aim of curing it.

There are some reasons why you wouldn't be able to join. For example, if you've recently taken certain antibiotics (within the last 2 months) or strong medicines that affect your immune system, like chemotherapy (within the last 6 months). Also, if you've been taking very large amounts of probiotic supplements (like certain yoghurts or drinks with many good bacteria) in the past year, or if you have certain bowel conditions like inflammatory bowel disease (Crohn's or colitis), coeliac disease, or a history of colorectal cancer or certain bowel operations.

Basically, we're looking for men with a specific type of prostate cancer who are having a standard radiotherapy treatment, and who haven't had recent treatments or conditions that might affect their gut bacteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged 18 or older?
Have you been recently diagnosed with prostate cancer that needs radiotherapy?
Are you planning to have 4 weeks of standard radiotherapy (IMRT) for your prostate?
Have you avoided certain antibiotics or strong immune-suppressing medicines recently?
Do you not have conditions like inflammatory bowel disease or a history of colorectal cancer?
Have you avoided very high doses of probiotic supplements in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to provide several types of samples and fill in some questionnaires. Before you start your radiotherapy, you'll give a poo sample, a pee sample, and a blood sample (around 40mls, which is about 3 tablespoons). You'll also fill out a health questionnaire about your quality of life and complete a simple 4-day food diary. You might also be asked to give an optional sample using a rectal swab (a small cotton bud).

During your 4 weeks of radiotherapy, you'll repeat these sample collections (poo, pee, blood, optional rectal swab) and the health questionnaire every week. After your radiotherapy finishes, you'll come back for follow-up appointments at 6-8 weeks, 6 months, and 12 months. At these appointments, you'll again provide the samples, complete the health questionnaire, and do another 4-day food diary. Your total time participating in the study, from start to finish, would be about 12 months.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information collected could help doctors better understand and manage tummy side effects from radiotherapy for future patients with prostate cancer. The main risks involve the blood tests, which can sometimes cause a little bruising or soreness, and the process of collecting samples, which some people might find a bit uncomfortable or inconvenient. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust
Verified postcode
Preston, United Kingdom· Recruiting

Common questions

What is radiotherapy?

Radiotherapy uses high-energy rays to destroy cancer cells and is a common treatment for prostate cancer.

What are gut bacteria?

These are trillions of tiny living germs, mostly helpful, that live in your gut and help with digestion and overall health.

Do I have to give all the samples?

You'll be asked for poo, pee, and blood. The rectal swab is optional, meaning you don't have to provide it if you don't want to.

How long will I be in the study?

You will be in the study for about 12 months, including your radiotherapy treatment period and follow-up appointments.

Will this affect my prostate cancer treatment?

No, your radiotherapy treatment will be given as usual, and taking part in this study won't change how your cancer is treated.

How to find out more

Lois Gardner, PhD

lois.gardner@manchester.ac.uk 01612008863 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.