The research, led by Mayo Clinic, was presented in Boston at the American Society for Radiation Oncology annual meeting.
Robert Miller, M.D., leading author, a radiation oncologist at Mayo Clinic said: "Oral mucositis or mouth sores is a painful and debilitating side effect of radiation therapy. Our findings represent a new standard of care for treating this condition."
Not only are people with oral mucositis in severe pain, it is also hard for them to eat and swallow. The condition also increases their vulnerability to infection, potentially having a negative impact on patients' quality of life.
Previous research indicated CAPHOSOL results in low rates of oral mucositis and pain in head and neck cancer patients who are receiving chemotherapy and radiation therapy.
Dr. Miller explained that the negative reactions people experience when they take narcotic pain medications are not seen with doxepin rinse.
The researchers conducted a Phase III trial in order to examine the effectiveness of doxepin oral rinse compared to a placebo. The study consisted of 155 head and neck cancer patients receiving radiation therapy.
Subjects got a single dose of doxepin on the first day, and then switched over to a placebo with no active ingredient on a later day.
A pain questionnaire was also given to each participant to fill out. They had to describe their pain associated with oral mucositis on a scale of 0 to 10 at baseline, and then at 5, 15, 30, 60, 120, and 240 minutes after doxepin rinse.
The participants were given the option to keep rinsing with doxepin after the trial was completed. Sixty-four percent of them chose to continue with the treatment.
Side effects reported by the patients included:
- unpleasant taste