Comparing BupiZenge Lozenges to Lidocaine for Oral Mucositis Pain Relief in Adults With Head and Neck Cancer

What this Trial Is About

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.