The tricyclic antidepressant doxepin reduces oral mucositis in patients who receive radiation for head and neck cancer, according to the results of a study presented at the 54th annual meeting of the American Society for Radiation Oncology in Boston, Massachusetts.
Treatment for head and neck cancer typically includes radiation therapy and/or chemotherapy. A common side effect of treatment for head and neck cancer is oral mucositis (OM), which is the irritation and inflammation of the lining of the mouth. Mucositis is associated with pain (which can interfere with eating and swallowing) and can lead to infection. If mucositis becomes severe, treatment may be delayed or doses reduced, which may lead to suboptimal outcomes from therapy.
Researchers conducted a multi-institution, randomized, double-blind, placebo-controlled, phase III trial to evaluate the efficacy of a doxepin oral rinse for the treatment of OM associated with radiation therapy. The study included 140 patients who received radiation therapy for head and neck cancer that involved more than one-third of the oral cavity. Patients had all reported OM pain scores above four (on a scale of 1-10) prior to the study. Throughout the study, patients completed OM pain questionnaires.
On the first day of the study, patients received a single, blinded dose of either doxepin rinse or placebo and then crossed over to the other study group on a subsequent day. In order to assess OM-related pain after the doxepin or placebo rinse, patients responded to a pain questionnaire at baseline and at 5, 15, 30, 60, 120, and 240 minutes. The study’s primary endpoint was total OM pain reduction as measured by the area under the curve (AUC) of the pain scale over time using data from day one.
Results indicated that doxepin significantly decreased pain on the pain scale over time. Analysis of the primary endpoint revealed that the pain reduction AUC was greater for doxepin (-9.1) vs. placebo (-4.7). Analysis of the crossover data revealed similar findings, with an AUC score of -7.9 in the doxepin group versus
-5.6 in the placebo group.
Doxepin was well tolerated. Patients who took doxepin reported increased stinging/burning, unpleasant taste, and increased drowsiness. After the study was completed, 64 percent of patients elected to continue taking doxepin.
The researchers concluded that OM pain was significantly reduced after doxepin compared to placebo. They suggest that this sets a new standard of care for the treatment of mouth pain associated with radiation therapy.
Miller RC, Leenstra J, Qun R, et al. N09C6 (Alliance) – A Phase III, Randomized Double-Blind Study of Doxepin Rinse versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Head and Neck Radiotherapy with or without Chemotherapy. Presented at the 54th Annual Meeting of the American Society for Radiation Oncology. October 28-31, 2012 Boston, Mass. Abstract LBA2.
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