Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients

Inclusion Criteria: * Histologically proven squamous cell carcinomas of the head-and-neck * Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx * Stage III or IV disease without evidence of distant metastases * Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy * Age ≥ 18 years * Karnofsky Performance Status ≥70 * Life expectancy ≥6 months * Able to swallow and retain oral medication * Good state of dentition * Patients must be available for treatment and follow-up * Confirmation of adequate contraception use by the patient and/or partner * Signed informed consent Exclusion Criteria: * Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx * Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities. * Chronic administration of steroids or immunosuppressants * Pregnancy.