Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

Inclusion Criteria: * Individuals regardless of gender older than 18 years * Patients diagnosed with squamous cell carcinomas \[SCCHN\] without metastases of other nonhead and nonneck tumors * Patients receiving radiotherapy with a Karnofsky performance index \>70% * Absence of any sign of oral mucositis at baseline (visit 1) * A definitive or postoperative treatment * Radiation therapy dosage: Limitation dose rate of 60-70 Gy * Radiotherapy of 6-7 weeks duration Exclusion Criteria: * Subjects younger than 18 years * Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash * Pregnancy or breastfeeding women * Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial * Patients who had a history of previous radiotherapy in head-neck region or chemotherapy * Massive alcoholic anamnesis * Massive smoker \>20 cigarettes per day at present