An oral rinse of the antidepressant doxepin significantly eased pain associated with oral mucositis in patients receiving radiation therapy for cancers of the head and neck, a study led by Mayo Clinic found. The findings were presented at the American Society for Radiation Oncology annual meeting in Boston.
"Oral mucositis or mouth sores is a painful and debilitating side effect of radiation therapy," says principal investigator Robert Miller, M.D., a radiation oncologist at Mayo Clinic. "Our findings represent a new standard of care for treating this condition."
Doxepin rinse does not cause the side effects associated with narcotic pain medicines, Dr. Miller says.
The Phase III study assessed the effectiveness of doxepin oral rinse versus placebo in 155 patients receiving radiation therapy for head and neck cancer. Patients received a single blinded dose of doxepin on day one and crossed over to the opposite study arm on a subsequent day. Patients reported pain associated with oral mucositis on a pain questionnaire with a scale of 0 to 10 administered at baseline and then at five, 15, 30, 60, 120 and 240 minutes after rinsing with doxepin. Patients could continue doxepin after the study, and 64 percent did so. Doxepin was well tolerated, though stinging, burning, unpleasant taste and drowsiness were reported as side effects.