Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

Inclusion Criteria: * diagnosis of head and neck cancer * planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy * able to eat at least soft solids * normal cardiac function * able to perform oral rinse Exclusion Criteria: * Induction chemotherapy regimen * life threatening allergic reaction to food and/or drugs * history of any other primary malignancy diagnosed within the past 5 years * prior radiation to the sites to be treated * active infections of the oral cavity