Oral Rinse Doxepin Relieves Painful Mucositis in Head and Neck Cancer

English: Doxepin Polski: Doxepin - Doksepina (Photo credit: Wikipedia)

The ASCO Post: "Doxepin oral rinse significantly improved oral mucositis in patients treated with radiation therapy for head and neck cancer according to results of a phase III trial presented at the 54th Annual Meeting of the American Society for Radiation Oncology (ASTRO) in Boston. However, the improvement was modest."

Study Details

"N09C6 was a double-blind, randomized, placebo-controlled trial of 140 patients with head and neck cancer who had oral mucositis pain scores above 4 (out of 10). Patients with head and neck cancer were enrolled between December 2010 and May 2012 and treated with radiation at doses above 50 Gy involving more than one-third of the oral cavity. Patients assigned to doxepin used an oral rinse at a dosage of 25 mg in 5 mL of water for 1 minute on day 1; patients then crossed over to the other treatment arm on day 2. Continued treatment with doxepin was allowed on an as-needed basis.

Pain was measured by the area under the curve (AUC) on a pain scale over time. On day 1, doxepin-treated patients reported a pain reduction to –9.1 vs –4.7 for placebo recipients (P = .0003). Crossover data from day 2 showed similar findings, with an AUC pain score of –7.9 in the doxepin group vs –5.6 in the placebo group (P = .009).

Doxepin was well tolerated, but 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 score at 5 minutes of 2.9 for doxepin vs 1.6 for placebo), and caused greater drowsiness (mean drowsiness score of 3.9 for doxepin vs 2.8 for placebo). During the optional continuation phase, the majority of patients (64%) elected to continue doxepin."

64% of patients chose to continue doxepin after study completion.

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From Oncology Times:

"Patients were asked to rate their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes later. The median pain score at baseline was 5.5 points, “which is the point at which it starts to interfere with eating and drinking,” he said.

During the four-hour period after the drug was administered, pain scores dropped an average of one point in the  placebo group compared with two points for the doxepin group, a significant difference, he said. After the two-day period two-thirds of patients elected to continue doxepin."

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“There are many, many local institutional recipes for mouth rinse and numbing rinses, so it is nice to see a controlled trial. However, the trial looks at only one single aspect of oral mucositis -- pain, and I would like to have seen swallowing and other endpoints evaluated as well.”

He also questioned how clinically meaningful “a transient improvement of one point on a 10-point pain scale really is to patients who are already on narcotics. Perhaps the same could be achieved by giving them one extra pill when they have breakthrough pain, rather than introduce an entire new class of drugs with its own set of side effects.”

The fact that patients on placebo improved one point on the pain scale could be just “a wonderful testament to the placebo effect,” Harari added.

The bottom line: Before the doxepin rinse is considered for widespread use, there should be a Phase III trial comparing the rinse with an extra narcotic capsule or with a numbing rinse, rather than placebo, he said."

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