Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation session - intraoral | Device | — | UNRESOLVED |
| Photobiomodulation session - transcutaneous | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Intraoral PBM
- interventionNames
- Device: Photobiomodulation session - intraoral
- type
- OTHER
- label
- Transcutaneous PBM
- interventionNames
- Device: Photobiomodulation session - transcutaneous
Primary outcomes (1)
- measure
- Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
- timeFrame
- Until OM resolution, up to 12 weeks
- description
- Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEber J, Schohn A, Carinato H, Brahimi Y, Schmitt M, Noel G. A Pilot Study Comparing Intraoral and Transcutaneous Photobiomodulation for Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy or Chemoradiotherapy. J Clin Med. 2025 Apr 2;14(7):2430. doi: 10.3390/jcm14072430. PMID 40217880