A study comparing 2 possible tests to check how well people can swallow after having their voice box removed to treat laryngeal 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

Status:

Closed

Phase:

Phase 1

This study is looking for a test to help doctors check how well people can swallow with a speaking device after surgery to remove the voice box. This is part 1 of a study looking to improve quality of life for people who have had a laryngectomy for cancer of the voice box (laryngeal cancer). Part 2 is a study looking at the impact of different speaking devices on speaking and swallowing.

If you have cancer of the voice box (laryngeal cancer) that is advanced, you may have surgery to remove your whole voice box (a total laryngectomy). But afterwards, you may have difficulty swallowing (dysphagia). And if you have a device fitted to help you speak again (a voice prosthesis), it sits in a passage the surgeon makes through the wall between your food pipe and wind pipe. So swallowing can take a lot of time and effort.

We know that people who have had a laryngectomy can feel that their quality of life is not so good afterwards. So, instead of just helping the person to speak again after laryngectomy, doctors now aim to improve people’s quality of life after surgery. They look at taste, smell and being able to enjoy eating in company again.

But there is no standard way of testing how well people can swallow after laryngectomy. This study is testing 2 possible ways to do this. The first is a type of X-ray called a videofluroscopy. The second uses a small thin tube with a tiny camera at the end, called a nasendoscope. The doctor puts the scope down your nose, and the camera records how you swallow. This test is called fiberoptic endoscopy. The aim of this study is to see which test works best for people who have had a laryngectomy and voice prosthesis.

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 30 people.

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

The staff at the unit will ask if you have any food allergies. The researcher will gently put a small thin tube with a camera at the end (a scope) through your nose and into your throat. They will then take some X-rays and also record what the scope sees while you have some swallowing tests.

The staff will give you 3 small helpings of each of the following foods and liquids to swallow

Thin liquids
A smooth food without lumps, such as custard (a puree)
A piece of banana
A piece of digestive biscuit

You then turn to face a different direction, and have one more helping of each of the foods and liquids you had before.

Each helping will be mixed with barium, to help the team see it clearly on the X-ray. Once you have swallowed all of these helpings, the team will gently remove the tube from your nose. The X-ray and camera pictures will be recorded onto a DVD so that the team can study them after your appointment.

You then fill out a short questionnaire about how you found the swallowing tests. You can then ask the team any questions you may have.

Hospital visits

You make one extra visit to hospital to take part in this study. This visit will last about an hour.

Side effects

The amount of radiation from the study test is very small. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The total amount of radiation you would have from the test is about the same as 89 days of background radiation, and is thought to be low risk.

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

It is possible that the barium mixed into the food you swallow as part of the tests may block your voice prosthesis, making you lose your voice for a few moments. This can be put right by cleaning the prosthesis.

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