An interventional study of Photobiomodulation session - intraoral and Photobiomodulation session - transcutaneous in Head and Neck Neoplasms, sponsored by Centre Paul Strauss. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Centre Paul Strauss · Not applicable, Interventional, and Prevention
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Centre Paul Strauss is the lead sponsor of 31 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Photobiomodulation session - intraoral
Device: Photobiomodulation session - transcutaneous
use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)
Number of cancelled radiotherapy sessions in comparison to initial treatment plan
Time frame: Until OM resolution, up to 12 weeks
Duration of oral mucositis in both group (intraoral and transcutaneous PBM)
Number of days
Time frame: Until OM resolution, up to 12 weeks
Number of hospitals stays in both group (intraoral and transcutaneous PBM)
Number of unscheduled hospitalizations
Time frame: Until OM resolution, up to 12 weeks
Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)
Number of days from radiotherapy initiation until artificial nutrition introduction
Time frame: Until OM resolution, up to 12 weeks
Infection rate in both group (intraoral and transcutaneous PBM)
Infections graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
Food intake in both group (intraoral and transcutaneous PBM)
Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool
Time frame: Until OM resolution, up to 12 weeks
Pain level in both group (intraoral and transcutaneous PBM)
Measured with a visual analogic scale (VAS), graded from 0 to 10
Time frame: Until OM resolution, up to 12 weeks
Quality of life of patients in both group (intraoral and transcutaneous PBM)
Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module
Time frame: Until OM resolution, up to 12 weeks
Dry mouth rate in both group (intraoral and transcutaneous PBM)
Graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
Start is estimated for Jun 2026; primary completion for Nov 2029, 41 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 41 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Paul Strauss