Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Alliance for Clinical Trials in Oncology
Status
Completed
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT02229539
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.
Intervention
DLA (diphenhydramine, lidocaine and antacids) rinse, Placebo, doxepin hydrochloride oral solution
Condition
Acute Oral Mucositis Pain
Investigators
Robert Miller, MD, MS

See list of participating sites