Read article A trial to see if a carbohydrate can help reduce bowel problems after radiotherapy for prostate, womb or cervical cancer (The PRESident Study)
This trial is looking at whether a carbohydrate called fructo-oligosaccharide (FOS) can help reduce bowel problems after radiotherapy for prostate cancer, womb cancer (endometrial or uterine cancer) or cervical cancer.
If you have prostate, womb or cervical cancer you may have radiotherapy as part of your treatment. Unfortunately part of the bowel will also be treated. This can cause inflammation of the bowel, leading to diarrhoea, bleeding and discomfort or pain in the back passage (rectum). For most people these symptoms go away within a few weeks of finishing radiotherapy. But for some people they can be more long term. Doctors call this chronic radiation enteritis.
Sometimes, chronic radiation enteritis can get worse over time. This may be due to bacteria in the bowel. The researchers think that encouraging healthy bacteria to grow may help to control chronic radiation enteritis.
FOS is a natural carbohydrate found in many foods including wheat, artichokes, asparagus, leeks and onions. In a small trial FOS changed the number of healthy bacteria in people with inflammation of the bowel. And this improved their symptoms.
The aims of this trial are to find out if FOS can reduce bowel problems after radiotherapy for prostate, womb and cervical cancer.
Recruitment
Phase
Who can enter
You may be able to enter this trial if you are attending University College London Hospital and you are at least 18 years old and are either
- Having radiotherapy to treat prostate cancer
Or - Having chemoradiation including carboplatin and paclitaxel to treat womb cancer
Or - Having chemoradiotherapy with cisplatin to treat cervical cancer
You cannot enter this trial if you
- Are having radiotherapy to relieve symptoms only
- Have an infection
- Have had antibiotics in the past month
- Have had any probiotics or prebiotics in the past month – your doctor can confirm this
- Have applied a medicated cream to your back passage in the past month
- Have used suppositories or enemas in the past month
- Have or may have an inflammatory bowel disease for example ulcerative colitis or Crohn’s disease
- Have any other medical condition that could affect you taking part in this trial
Trial design
This is a phase 2/3 trial. It is a randomised trial. You will be put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
People in group 1 have FOS during their radiotherapy. People in group 2 have another carbohydrate during their radiotherapy. Both are powder that you add to your food or mix with water. You take it daily for 5 weeks.
You have a diary card to record
- Any bowel symptoms you might have
- When you took your carbohydrate
- How acceptable you found taking it
- Any other medications you take
The researcher will also ask you to fill out a questionnaire before you start treatment and 3 and 6 months after treatment. The questionnaire will ask about side effects and how you have been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have some tests before taking part in this trial. You have an examination of your back passage (sigmoidoscopy). And you provide a stool specimen.
During radiotherapy you see a member of the research team weekly to see how you are.
After 5 weeks, you have another sigmoidoscopy. After radiotherapy you see the doctor at 3 and 6 months. You have another sigmoidoscopy at 6 months.
Side effects
FOS and the other carbohydrate used in this trial can be part of a normal diet and the researchers don’t anticipate any serious side effects. But you may have some bloating of the tummy (abdomen) and an increase in wind (flatulence).
You may have some bleeding from the back passage after the sigmoidoscopy.
Location of trial
For more information
Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.
Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD
Chief Investigator
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