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Clinical Trials in France / NCT06458517
Starting soon Not applicable

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

NCT06458517 · tracked via the Priya Life Science France tracker
Sponsor
Centre Paul Strauss
Phase
Not applicable
Started
2026-06-15
Last updated
2026-06-05

Condition(s) studied

Head and Neck Neoplasms

Investigational drug(s) / intervention(s)

Photobiomodulation session - intraoralPhotobiomodulation session - transcutaneous

Photobiomodulation session - intraoral: use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Institut de cancérologie Strasbourg Europe Strasbourg France

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Other trials for the same condition

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) Active, not recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
First in Human Study of AZD9592 in Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06458517 on ClinicalTrials.gov ↗ ← All trials in France