NCT06017895 Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
| NCT ID | NCT06017895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Swallowing-induced Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2023-10-31 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 receiving radiotherapy for nasopharyngeal carcinoma.
Eligibility Criteria
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.
Contact & Investigator
Jian Guan, MD
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06017895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Swallowing-induced Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06017895 currently recruiting?
Yes, NCT06017895 is actively recruiting participants. Contact the research team at 51643930@qq.com for enrollment information.
Where is the NCT06017895 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06017895 clinical trial?
NCT06017895 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jian Guan, MD at Nanfang Hospital, Southern Medical University. The trial plans to enroll 178 participants.