Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Study Information
Alliance Study ID: A221304
NCT Study ID (ClinicalTrials.gov): NCT02229539
Alliance Committee: Cancer Control
Disease or Cancer Type: Head & Neck Cancers
Alliance Study Chair: Robert Miller, MD, MS
Status: COMPLETED
Study Description
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.
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