A study looking at laser therapy for people with head and neck cancer who have mouth sores (LiTEFORM)

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Nasopharyngeal cancer
Pharyngeal cancer

Status:

Results

Phase:

Pilot

This study used a weak laser light to see if it helped people with a sore mouth caused by radiotherapy.

It was for people who were due to have radiotherapy for one of the following head and neck cancers:

The study was open for people to join between 2017 and 2019. The team reported the results in 2022.

More about this trial

Radiotherapy is a main treatment for head and neck cancer Open a glossary item. Radiotherapy to the mouth can cause side effects such as painful sores and ulcers. This is called oral mucositis. This can make it difficult to talk and swallow drinks or food. 
 
When this trial was done, standard treatment Open a glossary item for oral mucositis included:

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

In this pilot study Open a glossary item doctors looked at a treatment for a sore mouth called low level laser therapy. Doctors shone a weak laser light on the lining of the mouth. Researchers thought the low level laser therapy could reduce mouth pain during and after radiotherapy. They also thought it could help to heal the mouth after treatment. The laser therapy was a new treatment when this study was done. 

In this study, everyone had standard treatment for a sore mouth and:

  • half had the low level laser therapy
  • half had the dummy (inactive) low level laser therapy 

They had this on the same days as radiotherapy treatment. This was Monday to Friday for 6 weeks. 

The main aim of this study was to see if laser therapy helps to treat a sore mouth in this group of people. 

Summary of results

The team had hoped to find 380 people to take part. 87 people joined the trial. It was difficult to find enough people to take part. Of those that did:

  • 44 had low level laser therapy to the mouth 
  • 43 had the inactive laser to the mouth 

Neither those taking part nor the hospital staff knew which laser was being used.

Mouth pain questionnaires 
The team used questionnaires during the study to assess mouth pain. People filled them in once a week during and after radiotherapy. The questionnaires asked about how people felt and if they had pain or difficulty swallowing.

The main timepoint the team looked at was 6 weeks after radiotherapy started. They used a score to measure how much mouth pain people had. Higher scores meant more mouth pain. Lower scores meant less mouth pain.

On average, the scores were:

  • 33 out of 54 in the low level laser group
  • 28 out of 54 in the inactive laser group 

The research team cannot say for sure that the differences in these results are down to the different treatments. This is because of the small number of people who took part. The difference in results could be due to chance.

Other findings
The team also found: 

  • some people found having the treatment sessions difficult
  • setting up a new service that delivered laser therapy at the same time as radiotherapy was more complicated than the team thought it would be 
  • there were problems that included arranging appointments, finding suitable rooms and having enough trained staff with time to deliver laser therapy

Conclusion
The team say it’s difficult to draw a firm conclusion about having low level laser therapy. This is because there weren’t enough people in the study. The team say more research needs to be done to find out for sure how well this treatment works. 

The researchers learned about how to set up a laser therapy service within the NHS as part of people’s treatment. This could help with future studies.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT
M Nugent and others 
Health Technology Assessment, 2022. Volume: 26, issue: 46.

Where this information comes from    
We have based this summary on the information in the article above. As far as we are aware, it has not been reviewed by independent specialists (peer reviewed Open a glossary item) or published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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

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)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14812

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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