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Doxepin rinse reduced radiotherapy-associated oral mucositis
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A doxepin hydrochloride rinse was associated with a statistically significant decrease in oral mucositis pain compared with placebo among patients who underwent head and neck radiotherapy, according to results of a randomized phase 3 study.
The effects of the 1-minute rinse were apparent during the entire 4-hour assessment period, researchers wrote.
Patients with head and neck cancers experience painful oral mucositis during radiotherapy.
In the double blind trial, researchers randomly assigned 155 patients to a doxepin oral rinse or placebo on day 1. The next day, patients received the opposite agent.
Patients completed questionnaires at baseline and at 5, 15, 30, 60, 120 and 240 minutes after treatment. At the completion of the 4-hour cycle, patients were asked if they would like to continue treatment with the mouthwash they received.
Pain reduction as measured by the area under the curve (AUC) of an 11-point analog pain scale (range, 0 to 10) served as the primary endpoint.
Results showed the AUC for mouth and throat pain reduction was greater with doxepin (-9.1) than placebo (-4.7; P<.001). Data from the crossover analysis indicated that mouth and throat pain was reduced with doxepin after patients completed both phases of treatment (P<.001).
Doxepin rinse was associated with more stinging/burning, unpleasant taste and greater drowsiness than the placebo rinse. However, more patients desired to continue treatment with doxepin (77.3% vs. 51.5% among patients who received doxepin followed by placebo, P=.0018; and 69.8% vs. 43.9% among patients who received placebo followed by doxepin; P=.004).
“The doxepin rinse resulted in more adverse effects than placebo, so it is not clear whether patients chose to continue doxepin rinses because they guessed that they were on doxepin or because pain reduction prevailed over the adverse effect profile,” the researchers wrote. “Despite this uncertainty, the majority of patients elected to continue doxepin rinse therapy after the initial test rinses and found repeated doses of doxepin to be beneficial.”
Disclosure: Miller reports research funding from Pfizer.
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