RecruitingNot ApplicableNCT06017895

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

178 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a doxepin mouth rinse (a medicated liquid) can help reduce severe pain caused by swallowing in people with nasopharyngeal cancer (a type of head and neck cancer) who develop radiation-related mouth sores during treatment. **You may be eligible if...** - You are 18 or older with confirmed nasopharyngeal cancer - You are currently undergoing radiation or chemoradiation treatment - You have radiation-related mouth sores causing significant swallowing pain (at least 4 out of 10 on a pain scale) - You are functional enough to complete questionnaires (ECOG 0–2) **You may NOT be eligible if...** - You are allergic to doxepin or similar antidepressants (tricyclics) - You are currently using a tricyclic antidepressant or MAO inhibitor - You have untreated oral fungal infection or oral herpes - You have untreated narrow-angle glaucoma or urinary retention - You have serious heart disease or recent heart attack - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGdoxepin solution

2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall

OTHERPlacebo

2.0 mL placebo sprayed to the posterior pharyngeal wall


Locations(1)

Southern medical university

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06017895