Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx

Inclusion Criteria: * Karnofsky performance scale \>= 60% * Diagnosis of pathologically confirmed malignancy involving one or more of the following sites: oral cavity, oropharynx extending down to the level of the supraglottic area, nasopharynx, maxillary sinus and parotid gland * high risk for developing oral and/or oropharyngeal mucositis due to radiation to head and neck areas * scheduled to receive a continuous course (eg, often six to eight weeks) of conventional or hyperfractionated external beam radiation for cancer of the head and neck region (subjects who had surgery prior to radiation are eligible) with or without concomitant chemotherapy * at least two oral tissue sites (not including areas of previous lesions, tumor, surgical resection, or the lips) must be included in the RT treatment volume and planned to receive a total radiation dose of 5500 cGy or higher, given in a single daily fraction of 180 to 220 cGy or twice daily fractions of 110 to 150 cGy Exclusion Criteria: * Known hypersensitivity to benzydamine HCl and/or any of the other components including alcohol, menthol, glycerin, flavoring agents, and preservatives * oral or oropharyngeal mucositis present at the time of entry into the study * treatment regimen consisting of noncontinuous radiation therapy * received chemotherapy within 21 days of entry into the study as defined by initiation of radiation * scheduled to receive or have received brachytherapy * chronically being medicated for conditions o…