Expert Point of View: Paul Harari, MD


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Formal discussant of this trial, Paul Harari, MD, University of Wisconsin School of Medicine and Public Health, Madison, commended the N09C6 investigators for conducting a randomized controlled phase III trial on symptom relief.

“Most phase III trials are conducted to evaluate a new cancer treatment regimen. We need more phase III trials like this that address challenging cancer treatment toxicities,” he noted. Another strength of this trial is that it was a multicenter effort, which adds to its strength and balance, he said.

Most cancer clinics currently use some form of anesthetic mouth rinse consisting of agents such as lidocaine, diphenhydramine hydrochloride, or aluminum hydroxide/magnesium hydroxide to assist with oral mucositis pain, Dr. Harari explained. These rinses provide only temporary relief, however. Patients with head and neck cancer typically receive narcotic analgesics as well to get through their radiation therapy course.

Transient Reduction

The current study showed a modest, 1-point reduction in pain score over placebo [although a 2-point reduction from baseline] during a 4-hour test period following doxepin rinse. Baseline median pain score was 5.5; score decreased to 4.5, after placebo rinse, “a beautiful example of the placebo effect,” Dr. Harari said. Doxepin treatment reduced the median pain score to 3.5.

“It is important to consider whether a transient 1-point reduction in pain score over placebo [on a 10-point scale] warrants introduction of a whole new class of agent in patients already receiving multiple medications. It may be possible to achieve the same or better relief with slight adjustment in narcotic pain medication or additional use of anesthetic mouth rinses,” Dr. Harari commented.

Dr. Harari suggested it would be valuable to compare the doxepin rinse with anesthetic mouth rinses used at many institutions, and to compare doxepin rinse against a slight adjustment in pain medication to gain a better appreciation of the ultimate value of introducing this new agent. “This would be a logical question to consider,” he said. ■

Disclosure:Dr. Harari reported no potential conflicts of interest.


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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...


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