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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Redution of swallowing-induced pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
placebo
Patients 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.
干预措施: Placebo (Other)
doxepin solution
Patients 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.
干预措施: doxepin solution (Drug)
结局指标
主要结局
Redution of swallowing-induced pain
时间窗: Baseline, and 10, 20, 30, 60 minutes after administration
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.
次要结局
- Total Drowsiness Increase(Baseline, and 10, 20, 30, 60 minutes after administration)
- Difficulty in Swallowing Different Food(Baseline, and 10, 20, 30, 60 minutes after administration)
- Total Taste of the Agent(10, 20, 30 and 60 minutes after administration)
- Total Stinging or Burning From the Agent(10, 20, 30 and 60 minutes after administration)
- Adverse Event Profiles(up to one day after administration)
- Patient Preference for Continuing Therapy With the Agent(60 minutes after administration)