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Recruiting Not applicable

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

NCT06017895 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-10-31
Last updated
2026-06-23

Condition(s) studied

Swallowing-induced Pain

Investigational drug(s) / intervention(s)

doxepin solutionPlacebo

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

Placebo: 2.0 mL placebo sprayed to the posterior pharyngeal wall

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Provide informed written consent. 2. Age ≥ 18 years. 3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy. 4. Physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx. 5. At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain. 6. Being able to complete the questionnaires independently or with assistance. 7. ECOG Performance Status 0, 1 or 2. Exclusion Criteria: 1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation. 2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration. 3. Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection. 4. Untreated narrow angle glaucoma within 6 weeks prior to registration. 5. Untreated urinary retention within 6 weeks prior to registration. 6. Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration. 7. Current serious heart disease or a recent history of myocardial infarction. 8. Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia. 9. Pregnant or lactating women.

Primary outcome measure(s)

  • Redution of swallowing-induced pain — 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.

Trial sites (1)

FacilityCityRegionStatus
Southern medical university Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06017895 on ClinicalTrials.gov ↗ ← All trials in China