Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers (RADIO-PBM)

June 4, 2026 updated by: Centre Paul Strauss

Pilot Observational Study of Transcutaneous and Intraoral Photobiomodulation in the Prevention and Treatment of Radiomucositis in Head and Neck Cancers Treated by Radiotherapy - RADIO-PBM Trial

The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral mucositis (OM) is defined as damage to the mucosa of the oral cavity; it can be due to chemotherapy or radiotherapy. The incidence of OM is 59 to 100% according to studies in patients with oral cavity or oropharyngeal cancer receiving radiotherapy.

Clinically, OM is characterized by erythematous changes in the mucosa, which can progress to oral ulcerations. It can significantly alter the quality of life, the ability to eat, cause weight loss in patients and interfere with the proper realization of anti-tumoral treatment. Additionally, OM may increase the risk of bacteremia and sepsis in immunocompromised patients.

So far, effective management strategies for OM and associated pain are still insufficient. A wide variety of topical and oral agents are available, but effectiveness is still lacking.

Photobiomodulation (PBM) therapy involves the application of visible or infrared light produced by laser diodes or light-emitting diodes (LEDs) to stimulate wound healing, reduce inflammation, and decrease pain.

PBM can be performed in two main ways: intraoral and transcutaneous. Intraoral PBM involves applying red or near-infrared light directly in contact with the oral mucosa, while transcutaneous PBM involves the application of infrared radiation to the skin. Both techniques have shown their effectiveness. Numerous trials have evaluated the impact of PBM in radiomucositis but its use in clinical practice is to date not widespread and heterogeneous.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intraoral PBM
Device: Photobiomodulation session - intraoral
use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Other: Transcutaneous PBM
Device: Photobiomodulation session - transcutaneous
use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
Until OM resolution, up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Number of cancelled radiotherapy sessions in comparison to initial treatment plan
Until OM resolution, up to 12 weeks
Duration of oral mucositis in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Number of days
Until OM resolution, up to 12 weeks
Number of hospitals stays in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Number of unscheduled hospitalizations
Until OM resolution, up to 12 weeks
Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Number of days from radiotherapy initiation until artificial nutrition introduction
Until OM resolution, up to 12 weeks
Infection rate in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Infections graded according to NCI-CTCAE V5.0 criteria
Until OM resolution, up to 12 weeks
Food intake in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool
Until OM resolution, up to 12 weeks
Pain level in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Measured with a visual analogic scale (VAS), graded from 0 to 10
Until OM resolution, up to 12 weeks
Quality of life of patients in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module
Until OM resolution, up to 12 weeks
Dry mouth rate in both group (intraoral and transcutaneous PBM)
Time Frame: Until OM resolution, up to 12 weeks
Graded according to NCI-CTCAE V5.0 criteria
Until OM resolution, up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Paul Strauss

Investigators

  • Principal Investigator: Jordan EBER, MD, Institut de cancérologie Strasbourg Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

November 15, 2029

Study Completion (Estimated)

November 15, 2029

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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