RecruitingPHASE3INTERVENTIONAL

Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

This study is investigating if a gentle light treatment, called Low-Level Laser Therapy (LLLT), can prevent or reduce severe mouth sores in children and young adults undergoing chemotherapy. Chemotherapy can often cause painful mouth and throat sores, known as mucositis, which can make eating and drinking very difficult. The study compares LLLT with a dummy treatment (placebo) to see if the laser therapy really makes a difference. Participants will be aged 4 to 25 years old and receiving certain types of chemotherapy known to cause these sores. The main goal is to find out if LLLT can help make chemotherapy treatment more comfortable for young patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

315

Start

29 Aug 2018

Estimated completion

01 Sep 2026

Mucositis Oral

What is this study about?

When children and young adults have chemotherapy, which is a strong medicine to treat cancer, it can sometimes cause unpleasant side effects. One common side effect is called mucositis, which means the lining of the mouth and throat becomes very sore, inflamed, and can develop painful ulcers. This can make it very hard to eat, drink, or even talk, and can make patients feel very unwell.

This study is looking at a treatment called Low-Level Laser Therapy (LLLT) to see if it can help prevent or reduce these severe mouth sores. LLLT uses a special, low-power light that is shone gently inside the mouth. The idea is that this light can help to protect the delicate cells in the mouth from the damaging effects of chemotherapy, or help them heal faster if they do get damaged. By making the treatment more comfortable, patients might have an easier time recovering.

To find out if LLLT works, some children and young adults in the study will receive the laser therapy, while others will receive a 'placebo' treatment. A placebo looks just like the real treatment but doesn't have the active laser light. This helps the researchers compare the results fairly and understand if the LLLT itself is causing any improvements, rather than just the idea of having a treatment. The study is particularly focused on those receiving chemotherapy that is known to cause severe mouth sores, including those having high-dose chemotherapy before a stem cell transplant.

Key takeaways

This study aims to prevent painful mouth sores in children and young adults on chemotherapy.
It uses a gentle light treatment called Low-Level Laser Therapy (LLLT).
LLLT is compared against a dummy treatment to see if it really works.
Participants are aged 4-25 and on specific high-risk chemotherapy.
The goal is to make chemotherapy more comfortable for patients.

Who may be eligible?

This study is looking for children and young adults between the ages of 4 and 25 years old. To take part, you should not have any mouth sores or problems in your mouth before starting chemotherapy that would stop you from having the laser treatment or chemotherapy itself. It's also important that you are able to cooperate by wearing special dark glasses and sitting with your mouth open during the short laser sessions.

You must be having chemotherapy that is known to carry a high risk of causing severe mouth sores. This includes certain types of high-dose chemotherapy often used before a stem cell transplant, as well as specific conventional chemotherapy treatments for various cancers. If you are a girl or young woman who could become pregnant, you will need a negative pregnancy test before starting the laser treatment.

Only patients being treated at specific centres that are part of this study can take part. If you have any questions about whether your chemotherapy is included or if you meet the other requirements, the study doctors or nurses can help you understand if this study might be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 4 and 25 years old?
Are you going to have chemotherapy known to cause severe mouth sores?
Do you have no mouth sores or major problems in your mouth right now?
Are you able to wear dark glasses and keep your mouth open during short treatment sessions?
Are you being treated at one of the study's special centres in France?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the Low-Level Laser Therapy (LLLT) or a dummy treatment (placebo). Neither you nor your doctor will know which one you are receiving – this is to make sure the results are fair. The laser treatment itself involves a small device that shines a gentle light into your mouth for a short period, typically during your chemotherapy sessions. You will need to wear special protective glasses during these sessions. You'll likely have these laser (or placebo) sessions regularly as long as you are having the chemotherapy that puts you at risk of mouth sores. The study team will regularly check the inside of your mouth to see if you are developing any sores and how severe they are. The total duration of your participation will depend on your chemotherapy schedule.

Potential risks and benefits

Taking part in this study may offer some potential benefits, as the Low-Level Laser Therapy aims to prevent or reduce painful mouth sores, which could make your chemotherapy treatment more comfortable. However, there's no guarantee that you will personally benefit. Potential risks of LLLT are generally considered low, but as with any treatment, there's a small chance of unexpected effects. The laser is a low-power device, and you will wear protective glasses to ensure safety. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Hôpital Robert Debré
Verified postcode
Paris, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Recruiting
CHU de Rennes
Verified postcode
Rennes, France· Recruiting

Common questions

What are mouth sores (mucositis)?

Mouth sores, or mucositis, are painful red patches or ulcers in the mouth and throat that can happen as a side effect of some chemotherapy treatments.

What is Low-Level Laser Therapy (LLLT)?

LLLT uses a gentle, low-power light to treat or prevent problems. In this study, it's hoped to protect the lining of the mouth from chemotherapy side effects.

Will I know if I'm getting the laser or the dummy treatment?

No, neither you nor your doctors will know if you are getting the real laser therapy or a dummy treatment (placebo). This helps make the study results fair.

How long will I need to have the laser treatment?

You will likely have the laser sessions regularly for as long as you are having the chemotherapy that puts you at risk of developing mouth sores.

Is the laser treatment painful?

No, the low-level laser treatment should not be painful. It involves a gentle light being shone into your mouth.

How to find out more

Léa Guerrini-Rousseau, MD

lea.guerrini-rousseau@gustaveroussy.fr +33 (0)1 42 11 67 41 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.