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

Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.

The purpose of this study is to:

• evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
• assess tolerability of SAMITAL and the impact on patients reported outcomes.

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.