Actively Recruiting
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-12-27
178
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed written consent.
- Age 18 years or older.
- Confirmed nasopharyngeal carcinoma and currently undergoing radical radiotherapy or chemoradiotherapy.
- Presence of radiation-induced mucositis in the oral cavity and/or oropharynx.
- Patient-reported swallowing-induced pain score of at least 4 out of 10.
- Ability to complete questionnaires independently or with assistance.
- ECOG Performance Status of 0, 1, or 2.
You will not qualify if you...
- Known allergy to doxepin, tricyclic antidepressants, or any component of the drug formulation.
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days before enrollment.
- Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection.
- Untreated narrow angle glaucoma within 6 weeks before enrollment.
- Untreated urinary retention within 6 weeks before enrollment.
- Received cryotherapy to prevent oral mucositis within 6 weeks before enrollment.
- Current serious heart disease or recent myocardial infarction.
- Untreated or unresolved epilepsy, hyperthyroidism, hepatic dysfunction, delirium, or neutropenia.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Southern medical university
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
J
Jian Guan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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