by Brendon Nafziger
, DOTmed News Associate Editor
Patients with head and neck cancers who receive radiation therapy often develop painful mouth and throat sores. But an antidepressant mouth rinse might help make the pain more bearable, according to a study presented Monday at ASTRO 2012 in Boston.
The double-blind, phase 3 randomized control trial found a mouthwash made of Doxepin, a tricyclic antidepressant, outperformed a placebo rinse in relieving pain from oral mucositis. Also, two-thirds of patients who tried the Doxeprin wash found it helpful enough to ask for a prescription for it.
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"We think it can be used in addition to other (pain relief) agents at this point," study author Dr. Robert C. Miller, a radiation oncologist with Mayo Clinic in Rochester, Minn., told reporters during a press conference Monday. "It's not going to get rid of narcotics, but hopefully it will help people take less."
Doxepin goes by the brand names Adapin, Silenor and Sinequan.
The study, which took place in 26 institutions and involved 155 patients, followed patients for about four hours after receiving their first round of radiation and either a placebo or the Doxepin rinse. For their next fraction, the patients were crossed over to the other rinse.
According to Miller, patients just swishing around a placebo rinse, which was basically just water, experienced pain relief: pain went down an average of 1 point on a 10-point scale. With Doxepin, pain went down about 2 points on average, for a statistically significant difference, he said.
When asked whether they'd like to continue with the Doxepin rinse, 64 percent asked for a prescription, he said.
The Doxepin rinse had no serious side effects, but it did have some mild ones, such as a temporary burning sensation or unpleasant taste. Between 10 and 40 percent of people also experienced drowsiness after using it, and Miller said many patients preferred to take it at night, to help them sleep.
"Compared to placebo, we think Doxepin is an effective agent to reduce pain from oral mucositis," he said.
He also said the drug might be useful in other areas besides oral mucositis pain control - such as for people with nasty canker sores.
The study, "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," was part of a series given at ASTRO on patient outcomes and perspectives on radiation treatment. It was conducted with the Alliance for Clinical Trials in Oncology.
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