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Can light be the new shield against radiation mouth sores?

NCT ID NCT06458517

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests two light therapy devices—one placed inside the mouth and one outside—to prevent and treat painful mouth sores caused by radiation therapy. Sixty adults with oral cavity or oropharynx cancer will receive light sessions twice a week for prevention, then three times a week if sores appear. The goal is to see which device works better at reducing severe sores and treatment delays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
light therapy (photobiomodulation) via CareMin650TM intraoral device and ATP38® transcutaneous device
What this could lead to
If successful, this could point toward a standard way to reduce painful mouth sores during radiation therapy for head and neck cancer.
What could go wrong
This is a small pilot study with only 60 people, so results may not apply to everyone. It is also not yet recruiting, so outcomes are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patient (18 years old and older); * Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy; * Karnofsky Performance Status \> 60%; * Able to understand French; * With signed informed consent; * Affiliated to French Health Security Insurance Exclusion Criteria: * Allergy to polyurethanes; * Head and Neck tumors that are localized to other sites than oral cavity or oropharynx * Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations) * Pregnant and breastfeeding woman; * Patients with pacemaker device * Epileptic patients; * Concomitant treatment or treatment within the 7 days before inclusion with one of several drugs from the following list: fluoroquinolones, cycline, methotrexate, auranofin * Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage) * Patients under judicial protection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033, France

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