NCT06017895

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Swallowing-induced Pain

Interventions

Type	Name	Description
DRUG	doxepin solution	2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
OTHER	Placebo	2.0 mL placebo sprayed to the posterior pharyngeal wall

Timeline

• Start date: 2023-10-31
• Primary completion: 2026-02-15
• Completion: 2026-02-28
• First posted: 2023-08-30
• Last updated: 2024-12-27

Locations

1 site across 1 country: China