Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A study of a new diet for women with a blockage in the bowel (EDMONd)
This study is looking at a diet called elemental for women with a blockage in the bowel (bowel obstruction) caused by their cancer.
It is for women with a bowel obstruction caused by ovarian or primary peritoneal cancer, who can’t have treatment with surgery.
More about this trial
Surgery to by-pass the bowel obstruction is one of the main treatments. But surgery isn’t always possible, so your doctor might suggest other treatments to give the bowel time to rest. This may fix the blockage.
You need to stop eating and drinking until your bowel is working normally again. During this time, you might have food through a vein. This is called parenteral nutrition (PN).
You need to stay in hospital to have PN, and there might be side effects from it. So, doctors are looking at a new type of diet called elemental to have instead of PN.
An elemental diet is a drink that is already digested. It contains:
- broken down proteins
The main aim of this trial is to see if the elemental diet can help people with bowel obstruction.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if you are a woman and all of the following apply:
- you have ovarian or primary peritoneal cancer that has spread to other parts of the body (metastatic)
- your cancer caused a blockage in the bowel (bowel obstruction)
- you can drink about 500ml of liquid
- you are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply:
- you have a complete bowel obstruction (your doctor can check for this)
- your doctor thinks you can have surgery to treat the bowel obstruction
This is a feasibility study. Researchers hope that around 34 people from the UK will take part.
You see a dietician before you start on the new diet. They tell you how many elemental drinks you need to have every day.
You continue having the elemental drinks for 2 weeks. You can have other drinks such as black tea and coffee, squash and clear soup. Your nurse or dietician can tell you which drinks you can have.
You have a diary and the trial team will ask you to keep a record of:
- how many elemental drinks you have every day
- which flavours you prefer
- any other drinks you might have
You return the diary to the trial team when you finish the drinks.
Everyone taking part in this study completes a questionnaire on the 1st day of the new diet and then after 1 and 2 weeks.
The questionnaire asks about:
quality of life
- any symptoms you might have, such as pain and feeling or being sick
The study team may ask you to meet a research nurse. They will ask about your experience of taking part in this study.
You don’t have to agree to this interview if you don’t want to. You can still take part in this study. Researchers hope that around 8 women will agree to have the interview.
You see a doctor and have a physical examination before taking part. A dietitian or research nurse will see you and tell you how many drinks you need to have every day. They give you the drinks and the diet diary.
You have the elemental drinks for 2 weeks. During this time, you speak with a research nurse every week. This is to check how you are, and what medications you have taken.
The study team will monitor you while you are having the elemental drinks. They will give you a phone number to call them if you are worried about anything.
The team thinks the side effects of the elemental diet are:
- feeling or being sick
- tummy (abdominal) pain
- loose stools (poo)
How to join a clinical trial
Dr Agnieszka Michael
Royal Surrey County Hospital NHS Foundation Trust
Target Ovarian Cancer
University of Surrey