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Doxepin rinse significantly reduced oral mucositis pain
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The tricyclic antidepressant doxepin reduces oral mucositis when used as a mouth rinse, according to findings of a randomized study presented at the 2012 American Society for Radiation Oncology Annual Meeting in Boston.
Oral mucositis (OM) is a significant toxicity in patients who receive radiotherapy for head and neck malignancies. Previous research suggests the use of doxepin reduces radiotherapy-induced OM when used as a mouth rinse, according to background information provided by researchers.
Robert C. Miller
Robert C. Miller, MD, a radiation oncologist at Mayo Clinic in Rochester, Minn., and colleagues assessed the efficacy of doxepin oral rinse compared with placebo for the treatment of OM in a multi-institution, randomized, double blind, placebo-controlled, phase 3 trial.
The researchers enrolled 140 patients who received >50 Gy of radiotherapy for their head and neck cancers, involving more than one-third of the oral cavity, from December 2010 to May 2012. In that time, patients completed a pain questionnaire to numerically rate their OM pain on a scale of 1 to 10.
The study protocol called for patients to receive 25 mg of doxepin in 5 mL of water or placebo.
At baseline, all patients included in the study reported OM pain scores of at least 4.
On the first day of protocol, patients received a single, masked dose of doxepin rinse or placebo. Patients then crossed over to the opposite study group on a subsequent day.
They received the questionnaire at baseline, as well as at 5, 15, 30, 60, 120 and 240 minutes after receiving the rinse.
Researchers measured pain by the area under the curve (AUC) on the pain scale over time.
The addition of doxepin significantly decreased pain, Miller said.
Patients who received doxepin reported a reduction in pain to a –9.1, compared with –4.7 (P=.0003) for patients who received the placebo.
Crossover data revealed similar results.
The doxepin group revealed an AUC score of –7.9 vs. –5.6 (P=.009) for the placebo group.
Although doxepin was well tolerated, patients reported increased stinging/burning after the treatment (mean pain score, 3.7) compared with placebo (1.1). Doxepin increased unpleasant taste at 5 minutes (2.9 vs. 1.6 for placebo) and greater drowsiness (3.9 vs. 2.8 for placebo).
Still, 64% of patients chose to continue doxepin after study completion, Miller said.
“The majority of patients who received [doxepin] wanted to continue the drug,” he said. “We tested this in patients receiving radiation for head and neck cancers, but we think it may have applications outside of those areas, both in cancer as well as bad canker sores and ulcers.”
For more information:
Miller RC. Abstract #LBA2. Presented at: 2012 ASTRO Annual Meeting; Oct. 28-31, 2012; Boston.
Disclosure: Miller reports no relevant financial disclosures. Another researcher involved in the study reported an employment relationship with the International Journal of Radiation Oncology Biology Physics.