ASTRO: Study Affirms Efficacy of Doxepin Rise for Treatment of Oral Mucositis Pain

Doxepin oral rinse and Magic Mouthwash significantly reduce acute oral mucositis pain, in contrast with placebo, among patients with head and neck cancer receiving radiotherapy with or without chemotherapy, according to a study presented at the 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting.¹

Radiotherapy-induced oral mucositis is a major cause of comorbidity among patients with head and neck cancer. A large, randomized clinical trial conducted in 2012 demonstrated that doxepin oral rinse reduced oral mucositis pain, and although Magic Mouthwash, a lidocaine-based rinse often with diphenhydramine and an antacid, is widely used for the treatment of oral mucositis pain, no large randomized controlled trial has evaluated its efficacy.

For the multicenter, double-blind, phase 3 trial (Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy; ClinicalTrials.gov Identifier: NCT02229539), investigators enrolled 275 patients receiving head and neck radiotherapy with or without chemotherapy.

Participants were randomly assigned to receive a single dose of doxepin oral rinse, Magic Mouthwash, or placebo, and oral mucositis-related pain after the rinse was assessed using a pain questionnaire administered at intervals from baseline to 4 hours.

In contrast with placebo, oral mucositis pain was significantly less following both doxepin (P = .01) and Magic Mouthwash rinse (P=.004).

Patients in the doxepin group had less oral pain at 30 minutes (P = .03) and 60 minutes (P = .03) compared with placebo, while those in the Magic Mouthwash arm had significantly less pain at 5 minutes (P = .01), 15 minutes (P = .003), and 30 minutes (P = .004) post-rinse versus placebo.

Both agents were well tolerated, but doxepin-treated patients reported significantly more drowsiness at 30 minutes (P = .03) and 60 minutes (P = .01), as well as more fatigue than those who received placebo (P = .03).                                     

Reference

1. Miller RC, Le-Rademacher J, Sio TTW, et al. A phase III, randomized double-blind study of doxepin rinse versus magic mouthwash versus placebo in the treatment of acute oral mucositis pain in patients receiving head and neck radiotherapy with or without chemotherapy (Alliance A221304). Oral presentation at: 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting; September 25-28, 2016; Boston, Massachusetts.