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Doxepin Rinse Improves Oral Mucositis in Patients Treated With Radiation for Head and Neck Cancer

TOP - December 2012 VOL 5, NO 8 published on December 20, 2012 in Conference Correspondent

Doxepin, a tricyclic antidepressant approved for the treatment of depression and anxiety, as well as moderate pruritus, significantly improved oral mucositis pain in patients treated with radiation therapy for head and neck cancer in a phase 3 trial.1 In the study, doxepin was combined with water and used as an oral rinse.

Oral mucositis pain is a significant problem in patients with head and neck cancer treated with radiation, and treatments such as narcotics and mouth rinses are not particularly effective in alleviating this pain. Smaller studies have suggested that doxepin is safe and effective in reducing oral mucositis pain, and the present study establishes its effectiveness in a randomized controlled trial.

“Our study validates doxepin rinse as an effective way to alleviate oral pain and sets a new standard of care,” said the lead author of the study, Robert C. Miller, MD, of the Mayo Clinic in Rochester, Minnesota.

For the N09C6 study, pain was assessed on a visual analog scale and scored from 0 to 10, with a score of 10 signifying severe pain. N09C6 was a double-blind, randomized, placebo-controlled trial of 140 patients with head and neck cancer who had an oral mucositis pain score above 4 on the visual analog scale. Patients were enrolled between December 2010 and May 2012 and were treated with radiation at doses above 50 Gy involving more than one-third of the oral cavity for head and neck cancer. The dosage of the oral doxepin rinse was 25 mg dissolved in 5 mL of water and used for 1 minute. Patients were treated on day 1 with either the doxepin rinse or placebo; on day 2, patients crossed over to the other treatment arm. Patients could elect to continue treatment with the doxepin rinse on an as-needed basis.

On day 1, doxepin-treated patients reported area under the curve (AUC) pain score reduction to –9.1 versus –4.7 for placebo patients (P = .0003). Crossover data from day 2 showed similar findings, with an AUC pain score of –7.9 in the doxepin group versus –5.6 in the placebo group (P = .009).

Doxepin was well tolerated, but it was associated with more stinging and burning (mean pain score of 3.7 for doxepin vs 1.1 for placebo) as well as an unpleasant taste (mean unpleasant taste at 5 minutes 2.9 for doxepin vs 1.6 for placebo), and it caused greater drowsiness (mean drowsiness score of 3.9 for doxepin vs 2.8 for placebo). During the optional continuation phase, the majority (64%) of patients elected to continue doxepin.

Reference

  1. 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: American Society for Radiation Oncology 54th Annual Meeting; October 29, 2012; Boston, MA. Abstract LBA1.

 

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Last modified: July 22, 2021