Doxepin spray for pain relief in swallowing for nasopharyngeal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of doxepin solution spray in alleviating stubborn breakthrough pain caused by swallowing in patients with nasopharyngeal carcinoma undergoing radiotherapy. Participants with oral mucositis and significant swallowing-induced pain are randomly assigned to receive either the doxepin spray or a placebo before meals. Pain levels and adverse reactions are monitored through patient-reported questionnaires at various intervals after treatment. The study aims to provide insights into the pain management of patients suffering from radiation-induced complications.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southern medical university
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jian Guan, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Jian Guan, MD
• Email: 51643930@qq.com
• Phone: +86-13632102247

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observational study on a new method for managing radiation-induced mouth sores in cancer patients

  This study is testing a new method to see if it can help predict and manage mouth sores in cancer patients receiving radiation treatment for nasopharyngeal carcinoma.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong and 9 other locations · NCT06308328

• A method to predict radiation-induced mouth sores in cancer patients

  This study is testing a new way to predict if cancer patients receiving radiation for throat cancer will develop painful mouth sores, to help improve their treatment experience.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT06287788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.