Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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.
- mouth (oral) cancer
- oropharyngeal cancer
- nasopharyngeal cancer
- laryngeal cancer
More about this trial
- 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
- 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
- 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)
- 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
- 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
- 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
You have painkillers, mouth washes and special coating gels. Your doctor and nurse will tell you when and how to use them.
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
- when you finish radiotherapy
- after 4 months
- after 14 months
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.
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.
How to join a clinical trial
Mr Michael Nugent
The Newcastle upon Tyne Hospitals NHS Foundation Trust
NIHR Health Technology Assessment (HTA) programme
Newcastle Clinical Trials Unit (Newcastle University)