A Phase III, Randomized Double-Blind Study of Doxepin Rinse versus Magic Mouthwash versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Head and Neck Radiotherapy with or without Chemotherapy (Alliance A221304)

Oral mucositis (OM) is a major cause of morbidity during radiotherapy (RT) of the head and neck (H&N). “Magic Mouthwash,” a term encompassing a variety of lidocaine-based rinses, is widely used for OM but no large randomized controlled trials (RCT's) have shown it to be beneficial. In 2012, Doxepin oral rinse (DOX) was shown to reduce OM pain, compared to placebo, in a large RCT.