Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients … (NCT06017895) | Clinical Trial Compass
RecruitingNot Applicable
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
China178 participantsStarted 2023-10-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Redution of swallowing-induced pain
Timeframe: Baseline, and 10, 20, 30, 60 minutes after administration
Trial details
NCT IDNCT06017895
SponsorNanfang Hospital, Southern Medical University