Doxepin spray for pain relief in swallowing for nasopharyngeal cancer patients

Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patient Receiving Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial

This study is testing if a doxepin spray can help people with nasopharyngeal cancer manage pain when swallowing caused by radiation treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06017895 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed nasopharyngeal carcinoma undergoing radical radiotherapy or chemoradiotherapy and experiencing significant swallowing-induced pain.

Not a fit: Patients with known allergies to doxepin or tricyclic antidepressants, or those with untreated oral infections or specific medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients experiencing severe swallowing-induced pain due to radiotherapy.

How similar studies have performed: While the use of doxepin for pain management is established, this specific application for swallowing-induced pain in nasopharyngeal carcinoma patients is novel and has not been extensively tested.

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.

Where this trial is running

Guangzhou, Guangdong

• Southern medical university — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jian Guan, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Jian Guan, MD

Conditions Swallowing-induced Pain; Nasopharyngeal carcinoma; Oral mucositis; Radiotherapy; Swallowing-induced pain; Doxepin