Study of Dentoxol® Mouthrinse for Oral Mucositis

Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer

The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.

Inclusion Criteria:

• Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
• Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity

Exclusion Criteria:

• Unable to give written informed consent
• Known allergy/intolerance to any component of the study rinse or placebo
• Planning to use any contraindicated medications during the study period (pain medications are allowed)
• Age below 18 years
• Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)