Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial to see if fibre can help to control side effects in people having radiotherapy that affects the bowel
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at whether eating more or less fibre improves radiotherapy side effects to the bowel, in people having treatment to the area between their hip bones (pelvic radiotherapy).
If you have cancer, you may have radiotherapy as part of your treatment. Radiotherapy destroys cancer cells in the treated area. But it also affects healthy cells that are close by. New ways of giving treatment help to protect healthy tissue, but it can still be affected.
If you have radiotherapy to the organs in the area between your hip bones (your
Researchers in this trial are interested in how we can use diet to protect healthy
- If changing the amount of fibre you eat during your course of radiotherapy affects side effects
- Whether the amount of bowel that gets a particular dose of radiotherapy affects the side effects you have
Who can enter
You can enter this trial if you
- Have a women’s cancer (gynaecological cancer), bladder cancer, bowel cancer or cancer of the anus
- Are due to have radiotherapy aiming to cure your cancer rather than control symptoms
- Will be having radiotherapy every weekday for about 5 to 7 weeks
You cannot enter this trial if you
- Are not able to eat
- Are not able to digest wheat, or you need to avoid foods containing gluten (
- Are on a diet aimed at decreasing frequency of your bowel movements (a low residue diet), for a medical reason
- Have a tube fitted to relieve a blockage or keep open an area of your digestive system (gastrointestinal stent)
- Have a feeding tube going into your stomach (PEG tube) or the part of your small intestine called the jejunum (PEJ or JEJ tube)
- Have had surgery to form an opening of the bowel onto the surface of your tummy (colostomy)
- Are taking part in another study looking at side effects of treatment
This trial will recruit 177 people into 3 groups. This is a randomised trial. The people taking part will be put into groups by a computer. Neither you nor your doctor will be able to decide which group you are in. During your radiotherapy, you will either
- Start a low fibre diet
- Start a high fibre diet
- Carry on with the same types of food you usually eat
Everyone will meet with a
You will keep a food diary during the first and last weeks of your radiotherapy. And complete a chart to record and describe your stools throughout your treatment. You will meet the trial team to fill out a questionnaire each week and at the end of treatment. This will ask about your side effects, your diet and how you are managing. For these meetings, you will need to remember the food you ate the day before.
The trial team would also like to find out more about any extra costs you may have had in dealing with any radiotherapy side effects. If you are in groups 1 or 2, they will also ask about any costs involved in changing your diet and whether you enjoyed the diet.
Everyone will give a blood and stool sample
- When they start radiotherapy
- Halfway through their course of radiotherapy
- A year after treatment
You give your blood sample at the same time as any routine blood test you may be having. Both types of sample will help the team understand more about the changes that happen in your body during radiotherapy.
The team may ask if you would be willing to have 3 extra CT scans. This will help them to see how much of your radiotherapy is getting to your healthy bowel as well as to the treatment area. They will then see if there is a link between this and any bowel symptoms you have. These scans will be similar to CT scans you may have had before. The only difference is that you will drink a pint of fruit flavoured drink (contrast) before your scan. This shows the team an outline of your bowel on the scan, and helps them to measure what they see more easily.
Throughout the trial, you stay under the care of your regular cancer doctors.
You will make an extra hospital visit to see the dietician before you start your radiotherapy, to discuss your trial diet. You will also see the trial team a year after treatment.
If you agree to have the extra CT scans you will have these when you are already at the hospital for your radiotherapy. These scans last about an hour.
Everything else you do to take part in the trial will be during your hospital visits for your radiotherapy.
If you are in groups 1 or 2, you may have a change in your bowel habit as a result of changing how much fibre you eat. Because this fibre change is linked to the food you eat rather than fibre medication, your body should gradually get used to the change.
If you have the extra CT scans, the amount of extra radiation you will have is very small compared to your radiotherapy.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr HJN Andreyev
Dr S Essapen
The Royal Marsden NHS Foundation Trust