A study to help people with swallowing after treatment for head and neck cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasal and paranasal sinus cancer
Nasopharyngeal cancer
Pharyngeal cancer
Salivary gland cancer

Status:

Closed

Phase:

Other

Difficulty swallowing can be a long term problem for people who have surgery or radiotherapy to treat a head and neck cancer. 

More about this trial

You see a speech and language therapist Open a glossary item before and after treatment to get help with difficulty swallowing. They can give you exercises to do and some guidance about how to cope. 

This study is developing a new package to help with difficulty swallowing. It will use x-rays to see how you swallow. Based on the x-ray the speech and language therapist will give you exercises individually designed for you. 
        
This study has 2 parts. 

Part 1 is open to people who have had treatment for a head and neck cancer. In this part the study team ask people about their experiences of difficulty with swallowing after treatment. They use this to help them develop the package. 

Part 2 is open to people who are to have treatment for mouth (oral) cancer or a cancer of the back of the mouth and nose (pharynx). This part is a feasibility study. The researchers use the new swallowing package with a small number of people. This is to further develop the swallowing package for use in a large clinical trial. 

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. 

You may be able to join the 1st part of the study if all of the following apply. You are having treatment at University College London Hospital and you:

  • Have a head and neck cancer
  • Have finished treatment at least 3 months ago 
  • Were seen by the speech and language therapist before starting treatment
  • Are at least 18 years old

You may be able to join the 2nd part of the study if all of the following apply:

  • You have been newly diagnosed with mouth cancer or cancer of the area behind the mouth and nose (pharynx) 
  • Your cancer is bigger than 4cm across or has spread to 1 lymph node Open a glossary item in the neck (stage 3) or has spread into the surrounding tissue or to another part of the body (stage 4)
  • You are to have surgery to remove the cancer, chemoradiation Open a glossary item or a combination of both 
  • You are at least 18 years old

You cannot join this study if any of these apply:

  • You are already having treatment  
  • Your treatment is to control symptoms only and not with the aim to cure your cancer (palliative treatment) 
  • You aren’t having standard treatment Open a glossary item such as surgery or chemoradiation
  • You are only having 1 type of treatment for example brachytherapy Open a glossary item, chemotherapy or photodynamic therapy Open a glossary item
  • You have a brain tumour or any other type of cancer that isn’t a head and neck cancer

Trial design

This study is in 2 parts. 

Part 1
The study team need 10 people who are going to the University College London Hospital to join. 

A member of the study team will introduce the study to you at a routine clinic appointment. They then send out an information sheet by post. A week later they phone to see if you are still interested and to arrange a time for an interview. 

You have the interview at the hospital. The researcher asks about your experiences of the help you had with your swallowing after your treatment (swallowing rehabilitation). 

You watch a 5 minute presentation about a new therapy to help people with swallowing after treatment. The researcher will ask your thoughts about it. 

The interview takes about 45 minutes and will be audio taped. 

Part 2
This is a feasibility study. The team need 32 people going to the University College London Hospital to join. 

This is a randomised study. The people taking part are put into 1 of 2 groups by a computer:

  • usual care about swallowing
  • new swallowing package 

Diagram showing study ramdonisation

As part of the usual care your swallowing is assessed by a speech and language therapist before your treatment starts. They give you information about how the treatment will affect your swallowing and speech. And what happens after treatment during the rehabilitation process. 

As part of the new swallowing package you have an x-ray of your swallowing. You sit or stand with your back flat against a board. While taking the x-ray you are asked to swallow a small amount of liquid and food (yoghurt and biscuit) that is mixed with barium sulphate. This is a barium swallow x-ray. It takes about 10 minutes. 

You have 2 sessions with the speech and language therapist before your treatment starts. At the 1st session you have the x-ray. They show you the x-ray. And talk to you about your treatment and what impact it might have on your swallowing and speech. 

At the 2nd session they give you an individually tailored swallowing exercise programme. They also give guidance and education about swallowing. 

You start the exercises on the same day of the session. You continue to do them during treatment and afterwards. 

Questionnaires for Part 2
You fill in some questionnaires:

  • when you agree to take part in the study
  • then at 1 month after starting treatment
  • 3 months 
  • 6 months

The questions are about: 

  • your quality of life Open a glossary item
  • your experience of doing the exercises
  • how often you have done the exercises

Hospital visits

If you are in part 1 of the study you go to hospital for your interview. It takes about 45 minutes. 

If you are part 2 of the study and are having the new swallowing package you go to the hospital to have the x-ray and the first appointment with the speech and language therapist. This takes about 45 minutes. 

You have another appointment where you are given the individually tailored swallowing exercises. 

These appointments can be done on the same day or with a day or two between them.

After your cancer treatment your doctor will tell you how often they want to see you. 

Side effects

People in the new swallowing package group have an extra x-ray. 

The amount of radiation from this is very small and carries a very small risk of causing harm. It is equal to about 2 months of background radiation an adult would get from the environment in the UK.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Stuart Taylor

Supported by

NIHR Clinical Research Network: Cancer
NIHR Fellowships Programme
University College London (UCL)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12562

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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