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
Starting soon · Not applicable
Conditions studied: Head and Neck Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06458517
- Run by
- Centre Paul Strauss
- People needed
- 60
- Starts
- 2026-06-15
- Expected to finish
- 2029-11-15
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Institut de cancérologie Strasbourg Europe — Strasbourg, France
Full record on ClinicalTrials.gov
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