(ChemotherapyAdvisor) – Doxepin mouth rinse alleviates radiation therapy-associated mouth sore and oral mucositis (OM) pain among patients with head and neck cancer, according to a randomized, double-blind, placebo-controlled, crossover-design phase 3 trial presented at the American Society for Radiation Oncology’s (ASTRO’s) 54th Annual Meeting in Boston, MA.

“OM pain was significantly less following doxepin rinse than placebo,” reported lead author Robert C. Miller, MD, of the Mayo Clinic in Rochester, MN, and coauthors. “Our study validates doxepin rinse as an effective way to alleviate oral pain and sets a new standard of care for the treatment of pain due to radiation-related OM.”

The majority of patients in the study elected to continue doxepin during radiotherapy after the crossover portion of the study, Dr. Miller reported.

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The authors analyzed data for 140 study participants who underwent definitive head and neck radiotherapy (>50.0 Gy) including more than 1/3 of the oral cavity and oral mucositis pain self-reported as exceeding 4 on a scale of 0 to 10. Pain questionnaires were administered to patients at baseline, and at 5, 15, 30, 60, 120 and 240 minutes after rinsing with placebo or doxepin.

Pain reduction assessed as area-under-the-curve (AUC) was significantly greater for patients administered doxepin (-9.1) compared to placebo (-4.7; P=0.0003), the authors reported.

“Analysis of the crossover data revealed similar findings: doxepin (-7.9) vs placebo (-5.6), P=0.009,” Dr. Miller said.

“Doxepin was well tolerated, but had more rinse singing/burning and unpleasant taste, and caused greater drowsiness, compared to the placebo,” they noted. “64% of patients elected to continue doxepin (P=0.002) in the optional continuation phase.”