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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a spray called doxepin to help relieve severe pain that some patients experience while swallowing. This pain can occur in people receiving treatment for nasopharyngeal carcinoma, a type of cancer that affects the area behind the nose and throat. The researchers want to find out how well this spray works and if there are any side effects.

To participate, individuals need to be at least 18 years old, have a confirmed diagnosis of nasopharyngeal carcinoma, and be undergoing certain treatments like radiotherapy. They should also have noticeable pain while swallowing that rates at least a 4 out of 10 on a pain scale. Participants will complete surveys about their pain and experiences throughout the trial. However, some people won't be able to join, such as those with certain medical conditions or allergies. If you're interested, consult your doctor to see if you qualify and to learn more about what to expect.

Gender

ALL

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.