Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

Inclusion Criteria

• •1. Patient is 18 years of age or older;
• •2. Patient has a histologically documented diagnosis of cancer of the head and neck region;
• •3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;
• •This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:
• •3\. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:
• •1. patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
• •2. with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;
• •4\. Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;
• •5\. Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.
• •6\. The patient or guardian is capable of providing informed consent.
• •7\. If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.