A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

The purpose of this study is to test whether a mouthwash made with a drug called doxepin can
reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth
rinse preparations exist for patients with treatment-related oral mucositis pain such as the
DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin
compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by
the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term
pain management, as well as management of rash.