A study to look at the impact of different speaking devices on speaking and swallowing, in people who have had their voice box removed

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

Status:

Closed

Phase:

Phase 2

This study is looking to see which speaking devices (voice prostheses) people prefer for speaking and managing to swallow after surgery to remove their voice box (laryngectomy). This is part 2 of a study looking at improving quality of life for people who have had a laryngectomy for cancer of the voice box (laryngeal cancer). Part 1 was a study comparing 2 possible tests to check how well people can swallow after having their voice box removed.

If you have cancer of the voice box that is advanced, you may have surgery to remove your whole voice box. This is called a total laryngectomy. During surgery, your surgeon will make a passage through the wall between your food pipe and wind pipe. You can then have a device fitted that helps you to speak again. These devices are called voice prostheses.

There are several voice prostheses available. Some people say that certain prostheses are easier to swallow with than others. But so far there has been no research to look at this. The team also want to see if some voice prostheses are easier to talk with than others. This study will test Blom Singer and Provox devices.

The aim of this study is to look at the impact of different voice prostheses on swallowing and voice quality.

Who can enter

You may be able to enter this study if you

Are being cared for by Imperial College Healthcare NHS Trust
Have had surgery to remove your whole voice box (total laryngectomy), with or without removing the area above your vocal chords (supraglottis )
Have had a device fitted to help you speak (voice prosthesis)
Are between 20 and 100 years of age

You cannot enter this study if you

Have not had a voice prosthesis fitted
Have any condition that affects how well you can understand things (cognitive dysfunction)
Had your surgery, chemotherapy or radiotherapy after surgery for cancer of the larynx in the last 3 months
Would not be able to cope with having a thin tube with a camera at the end (nasendoscope) put down your nose

Trial design

This study will recruit 40 people.

Everyone will give the team permission to look at their medical notes, and will visit Charing Cross Hospital for some tests.

At the appointment, you or the team will remove your voice prosthesis, and the team will work out the most suitable size of new prostheses for you to test in the study. You will have 5 or 6 new prostheses to try, depending on your measurements.

The team will then fit each prosthesis in turn, using the ‘gel cap system’ when appropriate to make it as comfortable as possible.

For each prosthesis you try, you will read a short version of The Rainbow Passage, which is often used in voice tests. If you do not read English, you will read a translation of the passage in your own language. The team will record these readings to study later. You then fill out a short questionnaire to say what you thought of your voice.

The team will then pass a small thin tube with a camera on the end (a nasendoscope) through your nose. The camera will show your prosthesis on the screen. You then have 3 small helpings of each of the following

Thin liquid
Custard or similar blended (pureed) food
Banana, 1cm thick
Quarter of a digestive biscuit

After that, you read The Rainbow Passage again and fill out a short questionnaire. This questionnaire will ask about your experience of swallow and voice quality with the test prosthesis in place.

The team will then remove the prosthesis and repeat these tests with the next prosthesis, until you have tested the 5 or 6 in your size. If you find it too uncomfortable to try all of the test prostheses at one appointment, you can complete the tests at a second appointment.

Hospital visits

You will make one or 2 visits to the hospital to take part in this study. This will depend on whether you are able to test all the prostheses at one appointment, or if you would find it easier to do this over 2 visits. However many visits you make, each will take about 90 minutes.

Side effects

You may have some discomfort having a number of prostheses fitted in a quite a short space of time. You can do this over 2 appointments if this affects you.

You may faint or have a nose bleed when the team put the nasendoscope down your nose. But they think this will be unlikely.

It is possible that the food you swallow as part of the tests may block your voice prosthesis. This can be put right by cleaning the prosthesis.

If you have any problems during the tests, the team will stop them straight away.