Can light be the new shield against radiation mouth sores?
NCT ID NCT06458517
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
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Institut de cancérologie Strasbourg Europe
Strasbourg, 67033, France
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