Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma

Официальное название

Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patient Receiving Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial

Обзор

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.

Подробное описание

Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy who developed oral mucositis and had a swallowing-induced pain score ≥ 4 were recruited and randomly assigned 1:1 to the experimental group and the control group.

Patients in the experimental group received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating.

Patients in the control group received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating.

The swallowing-induced pain and incidence of adverse events were assessed at 10 minutes, 20 minutes, 30 minutes, and 1 hour after medication using a patient-reported questionnaire, and safety evaluation was conducted 1 day after treatment.

Вмешательства

• Препарат doxepin solution
  2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
• Другое Placebo
  2.0 mL placebo sprayed to the posterior pharyngeal wall

Первичные конечные точки

• Redution of swallowing-induced pain [Срок оценки: Baseline, and 10, 20, 30, 60 minutes after administration]

Вторичные конечные точки (6)

• Total Drowsiness Increase [Срок оценки: Baseline, and 10, 20, 30, 60 minutes after administration]
• Total Taste of the Agent [Срок оценки: 10, 20, 30 and 60 minutes after administration]
• Total Stinging or Burning From the Agent [Срок оценки: 10, 20, 30 and 60 minutes after administration]
• Difficulty in Swallowing Different Food [Срок оценки: Baseline, and 10, 20, 30, 60 minutes after administration]
• Patient Preference for Continuing Therapy With the Agent [Срок оценки: 60 minutes after administration]
• Adverse Event Profiles [Срок оценки: up to one day after administration]

Критерии участия

Критерии включения

• Provide informed written consent.
• 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.
• At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain.
• Being able to complete the questionnaires independently or with assistance.
• ECOG Performance Status 0, 1 or 2.

Критерии исключения

• 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.
• Untreated urinary retention within 6 weeks prior to registration.
• Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration.
• Current serious heart disease or a recent history of myocardial infarction.
• Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia.
• Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Southern medical university — Гуанчжоу

Идентификаторы

NCT: NCT06017895 · NFEC-2023-351

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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