The goal of this clinical trial is to explore the effectiveness and adverse reactions of doxepin solution spray for alleviation of stubborn breakthrough pain induced by swallowing in patients receiving radiotherapy for nasopharyngeal carcinoma.
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Age ≥ 18 years.
Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
Physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx.
Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation.
Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration.
Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection.
Untreated narrow angle glaucoma within 6 weeks prior to registration.
Crossover
doxepin solution
Drug2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
Placebo
Other intervention2.0 mL placebo sprayed to the posterior pharyngeal wall
Redution of swallowing-induced pain
The redution of swallowing-induced pain was measured by the numerical analogue scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Total Drowsiness Increase
The total drowsiness increase was measured by the numerical analogue scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Total Taste of the Agent
The total taste of the agent was measured by the numerical analogue scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Total Stinging or Burning From the Agent
The stinging or burning of the oral cavity/oropharynx was measured by the numerical analogue scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Difficulty in Swallowing Different Food
The difficulty in swallowing liquids, pureed food and solid food was measured respectively by the numerical analogue scale of 0 to 10, with 0=not at all and 10=very much in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
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