"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at two different ways of feeding during treatment for head and neck cancer (TUBE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at two different ways of tube feeding, alongside normal eating and drinking, for people having treatment for head and neck cancer.
One of the treatments doctors use to treat
When eating and drinking becomes difficult, you usually need a feeding tube for a short while during and following treatment. Food through a tube helps to stop weight loss and keep you well nourished.
Two standard ways of tube feeding include
- A tube put into your nose, down the throat into your stomach (called a nasogastric tube or NGT)
- A tube going through an opening on the outside of your abdomen into the stomach (gastrostomy tube)
Researchers want to know whether it is better for you to have a gastronomy tube put in before treatment, which you can use as well as eating normally as much as you can. Or whether you should try eating normally during treatment, but have a NGT put in if you need extra food.
Before researchers can find this out, they need to do a small trial to check whether a larger trial of this kind will work.
The aims of this feasibility trial are to
- Find out whether patients are willing to be put into these different groups by a computer and what they and their friends and relatives think of this trial
- Learn more about the side effects of the 2 ways of tube feeding
Who can enter
You may be able to join this trial if you have
- Cancer of the mouth and back of throat
- Cancer of the nose or sinuses
- Cancer of the voice box (larynx)
- Cancer of unknown primary of the head and neck
- You have cancer that is locally advanced or has spread (stage 3 or 4 cancer - your doctor can tell you what stage your cancer is, depending on your type of head and neck cancer)
- You are due to have a combination of radiotherapy and chemotherapy (
chemoradiation) as the primary treatment with the aim of curing your cancer
- You are able to eat a regular diet
You cannot join this trial if any of these apply. You
This is a feasibility trial. The researchers need about 60 people to join the trial.
It is a randomised trial. The people taking part are put into different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in one group have a gastrostomy tube put in place before their treatment
- People in the other group do not have a gastrostomy tube. You may have a NGT (nasogastric tube) during treatment if you need it
People in both groups will be encouraged to eat and drink normally as much as possible during
Your doctor or dietician may recommend that you have extra food through your feeding tube if you are losing weight, or finding it difficult to eat and drink. You will be shown how to put liquid food into your tube.
Whichever group you are in, you can have the tube removed as soon as you are well enough to eat a healthy balanced diet. A small number of people may need support with long term tube feeding.
The trial team will ask you to fill out a questionnaire before treatment, then 3 months, 6 months and 1 year after treatment. The questionnaire will ask about side effects, such as swallowing, and how you’ve been feeling. This is called a quality of life study.
The researchers will also ask if you would like to take part in an interview and whether you would mind being observed by a researcher at your clinic appointment. This is called the sub-study.
If you agree to an interview, the researchers will ask you what you think about this trial and about tube feeding. The trial team may also ask if they can interview some of your family and friends to get their thoughts on this trial.
If you agree to be observed, a researcher will observe or record the conversation you have with your doctor about taking part in this trial. The researchers want to find out what questions you and your friends and family ask about the trial.
If it up to you whether you want to be part of the sub-study. You can still take part in the main part of the trial if you decide not to do this part. Or you can decide to take part in the interviews and not the observation, or the other way around.
You go to hospital to see the trial nurse before you start treatment. They will weigh you and ask questions about your teeth (how healthy they are and what dental work you have had done) and about your diet.
You see the trial nurse to be weighed and assessed after your chemoradiation, then again after
- 3 months
- 6 months
- 1 year
Where possible, your appointments will be at the same time as your routine head and neck clinic appointments.
The researcher will treat everything you tell them
If you have a gastrostomy tube this could cause red, sore skin around the tube site. There is a small risk of your tube becoming infected or blocked.
If you have a nasogastric tube you could have some soreness and discomfort in your nose and throat. There is a small risk that your tube could fall out, or block.
Your head and neck team will show you how to look after your tube, how to use it and what to do if you have any problems.
The most common side effects of radiotherapy and chemotherapy together (
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.
Mr Vinidh Paleri
NIHR Health Technology Assessment (HTA) programme
Newcastle upon Tyne Hospitals NHS Foundation Trust