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

Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for 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