{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"19"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake.\n\nOral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.","groups":[{"description":"The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.\n\nlow level laser therapy","id":"OG000","title":"Laser Low-level Energy Functional"},{"description":"The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.\n\nplacebo (laser low level energy nonfunctional)","id":"OG001","title":"Laser Low-level Energy Nonfunctional"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment","title":"Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification","type":"PRIMARY","unitOfMeasure":"Participants"}