Study Researches Pain Reduction in Patients Receiving Head and Neck Radiotherapy

Study Sets a New Standard of Care for the Treatment of Oral Pain
Audio: 
Robert C. Miller, MD, Radiation Oncologist at the Mayo Clinic in Rochester, MN

ASTRO’s Annual Meeting is the premier scientific meeting in radiation oncology and is expected to attract more than 11,000 attendees including oncologists from all disciplines, medical physicists, dosimetrists, radiation therapists, radiation oncology nurses and nurse practitioners, biologists, physician assistants, practice administrators, industry representatives and other health care professionals from around the world.

The theme of the 2012 meeting is “Advancing Patient Care Through Innovation” and will examine how innovation in technology and patient care delivery can lead to improved patient outcomes. The four-day scientific meeting will include six plenary papers, 408 oral presentations, 1,724 posters, and 130 digital posters in 63 tracks/topic areas.

As part of this year’s conference, Robert C. Miller, MD, Radiation Oncologist at the Mayo Clinic in Rochester, MN, and colleagues are presenting the study to assess the efficacy of doxepin oral rinse and spit, versus placebo for the treatment of radiotherapy related inflammation and ulceration of the mucous membranes (Oral mucositis or OM) and conducted trials through the Alliance for Clinical Trials in Oncology.

Oral mucositis remains a significant toxicity in patients receiving radiotherapy for malignancies of the head and neck. Previous pilot research has suggested that doxepin, a tricyclic antidepressant, reduces radiotherapy induced OM when used as a mouth rinse. After completing the study, patients were given the option to continue doxepin. The study’s primary endpoint was total OM pain reduction as measured by the area under the curve of the pain scale over time using data from day 1.

Analysis of the primary endpoint revealed that the pain reduction was greater for doxepin. Analysis of the crossover data revealed similar findings. Doxepin was well tolerated, but had more rinse stinging/burning and unpleasant taste and caused greater drowsiness, compared to the placebo. Sixty-four percent of patients elected to continue doxepin in the optional continuation phase. OM pain was significantly less following doxepin rinse than placebo. This study sets a new standard of care for the treatment of oral pain due to radiation-related OM.

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