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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Photobiomodulation session - intraoral
  • Photobiomodulation session - transcutaneous

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators