Status:
RECRUITING
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Swallowing-induced Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 receivin...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06017895
Start Date
October 31 2023
End Date
February 28 2026
Last Update
December 27 2024
Active Locations (1)
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1
Southern medical university
Guangzhou, Guangdong, China, 510515