A study looking at whether laser therapy helps reduce the pain and impact of mouth sores in people having treatment for head and neck cancer (LiTEFORM)

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

Nasopharyngeal cancer

Pharyngeal cancer

Status:

Closed

Phase:

Pilot

This study is using a weak laser light to see if it helps people with mouth sores (oral mucositis). It is for people who are going to have radiotherapy for:

mouth (oral) cancer
oropharyngeal cancer
nasopharyngeal cancer
laryngeal cancer

More about this trial

Radiotherapy is one of the main treatments for head and neck cancer. It uses high energy waves similar to x-rays to kill cancer cells.

Radiotherapy to the mouth can cause side effects such as painful sores and ulcers. You might find it difficult to talk and to swallow drinks or food. This is called oral mucositis.

For oral mucositis, you usually have:

mouth washes to keep your mouth clean
painkillers and special coating gels to help with the pain

This is the standard treatment.

In this study, doctors are looking at a new treatment for oral mucositis called low level laser therapy.

Doctors shine a weak laser light on the lining of the mouth. They think the low level laser therapy can reduce the pain during and after radiotherapy. And help heal the mouth after treatment.

Everyone taking part in this study has 1 of the following:

low level laser therapy and the standard treatment for oral mucositis
dummy (inactive) laser therapy and the standard treatment for oral mucositis

The main aim of this trial is to see if laser therapy and standard treatment is better than the standard treatment alone for oral mucositis.

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.

Who can take part

You may be able to join this study if you have a squamous cell carcinoma (SCC) Open a glossary item

of the:

mouth
oropharynx
nasopharynx
larynx
hypopharynx
neck nodes and doctors can’t find the main (primary) tumour (unknown head and neck cancer)

All of the following must also apply. You:

are going to have radiotherapy, or radiotherapy with chemotherapy (chemoradiotherapy), as the main treatment to try to cure your cancer
are going to have a dose of at least 60Gy of radiotherapy (your doctor can tell you about this)
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply.

Cancer related

You:

have salivary gland cancer that started in the parotid glands
have had radiotherapy for head and neck cancer
are going to have a low dose of radiotherapy to help with symptoms (palliative radiotherapy)

Medical conditions

You:

have difficulty opening your mouth wide (trismus)
are at risk of bleeding from your mouth
have epilepsy that is triggered by flashing or flickering light (photosensitive epilepsy)
take drugs to damp down your immune system (immunosuppressant) such as steroids unless it is a small dose
are pregnant or planning to become pregnant during this study
are taking part in another clinical trial looking at the treatment of oral mucositis

Trial design

This is a pilot study. The researchers need 380 people who are going to have radiotherapy for head and neck cancer to take part in this pilot study.

The radiotherapy treatment you have is the same as if you were not taking part in this study. You have treatment every day, Monday to Friday, for 6 weeks. Your doctor can tell you more about this and what to expect.

Before you start radiotherapy, you meet with the study team. They ask you if you are happy to take part in this study and you can ask them questions too.

The team might ask to record this conversation. This is so they know what type of questions people ask about the study.

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

low level laser therapy and standard treatment
dummy (inactive) laser therapy and standard treatment

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which treatment you are having. This is a double blind trial. Open a glossary item

Laser therapy

You have a laser therapy session about 60 min before radiotherapy. You then have up to 3 laser therapy sessions every week, for 6 weeks. It takes about 20 to 30 minutes each time you have it. During each session:

you put on special glasses to keep your eyes safe and so that you don’t see which treatment you are getting
you open your mouth wide
the study team puts a small probe in your mouth (it does not need to touch your skin)
you hear a beeping noise when the machine is switched on
you have the laser treatment or the inactive laser treatment

Standard treatment
You have painkillers, mouth washes and special coating gels. Your doctor and nurse will tell you when and how to use them.

Questionnaires
You complete questionnaires at set times during this study. The questionnaires ask about how you feel and if you have pain or difficulty swallowing.

You complete a questionnaire every week for 6 weeks, and then after:

4 months
14 months

Swallowing test

The study team asks you to drink half a glass of water as quickly as you can. They want to check your swallowing and if it’s affect by the radiotherapy.

You have the swallowing test before the start of radiotherapy and then:

when you finish radiotherapy
after 4 months
after 14 months

Interview study

The study team might ask you to take part in an interview study. This is a separate study and you don’t have to agree to this if you don’t want to. You can still take part in the main study.

You have 2 telephone interviews with a member of the study team. Each interview takes between 20 and 40 minutes. You have an interview at the start of your treatment and then after 4 months or after 14 months.

The team wants to find out what you think about this study. The team might ask you to have an interview even if you don’t agree to take part in the main study.

Hospital visits

There are no extra hospitals visits as part of this study. You meet the study team and have the laser therapy when you go to hospital for your planned treatment.

After radiotherapy, your doctor will see you regularly to check how you are. This is the follow up. You have the swallowing test and complete questionnaires during the follow up appointments.

Side effects

The study team don’t think you will have any side effects from taking part in this study.

You may have eye problems if the laser therapy is shone in your eyes. But this risk is very small and you wear special glasses to protect your eyes.

You might have side effects from radiotherapy. The team will tell you about all the possible side effects before you have treatment.

We have information about the possible side effects of head and neck radiotherapy.

Recruitment start:

27/10/2017

Recruitment end:

31/03/2019

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Mr Michael Nugent

Supported by

The Newcastle upon Tyne Hospitals NHS Foundation Trust
NIHR Health Technology Assessment (HTA) programme
Newcastle Clinical Trials Unit (Newcastle University)

Freephone 0808 800 4040

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