TUBE Trial
Research type
Research Study
Full title
A feasibility randomised controlled trial of pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemo-radiation for head and neck cancer.
IRAS ID
145788
Contact name
Vinidh Paleri
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Research summary
Head and neck cancer is a serious problem affecting our society. Treatment involves chemo-radiation which will make eating and drinking more difficult and can affect swallowing. People undergoing this treatment are likely to require a feeding tube for a while during and following their chemo-radiation treatment.
Where feeding assistance is necessary it is currently provided by two standard and well established methods used in the NHS. These methods are:
1) fitting a gastrostomy tube known as a PEG (a feeding tube inserted into the stomach) BEFORE the beginning of chemo-radiation treatment. The gastrostomy tube is known as a PEG because of the tube’s medical name (Percutaneous Endoscopic Gastrostomy).
or
2) fitting a nasogastric tube known as an NGT (tube running through the nose into the throat and down to the stomach) when needed. This is usually sometime AFTER beginning chemo-radiation treatment when eating, drinking and swallowing becomes difficult.
Most people only need feeding tubes to help with feeding for a short time. Both options are good for keeping patients well-nourished during and following chemo-radiotherapy treatment however we do not know which of these options leads to a better swallowing ability or quality of life in the short- or longer-term. This is why we are studying the use of these two types of feeding tubes on patients’ short- and long-term quality of life.
This study is a “pilot or feasibility study” which will test the methods that we might use in a larger study on this subject in future. We need to do a pilot study in order to estimate how many people to include in a larger study and to be sure that we get the design of the study right. We will aim to recruit at least 60 patients into this study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/0045
Date of REC Opinion
27 Feb 2014
REC opinion
Favourable Opinion