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

NCT06017895 | Recruiting

• 1 other identifier: NFEC-2023-351
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing-induced Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Redution of swallowing-induced pain

  The redution of swallowing-induced pain was measured by the numerical analogue scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.

  Baseline, and 10, 20, 30, 60 minutes after administration

Secondary Outcomes (6)

• Total Drowsiness Increase

  Baseline, and 10, 20, 30, 60 minutes after administration

• Total Taste of the Agent

  10, 20, 30 and 60 minutes after administration

• Total Stinging or Burning From the Agent

  10, 20, 30 and 60 minutes after administration

• Difficulty in Swallowing Different Food

  Baseline, and 10, 20, 30, 60 minutes after administration

• Patient Preference for Continuing Therapy With the Agent

  60 minutes after administration

Study Arms (2)

doxepin solution

EXPERIMENTAL

Patients received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating.

Drug: doxepin solution

placebo

PLACEBO COMPARATOR

Patients received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating.

Other: Placebo

Interventions

doxepin solution DRUG

2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall

doxepin solution

Placebo OTHER

2.0 mL placebo sprayed to the posterior pharyngeal wall

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current serious heart disease or a recent history of myocardial infarction.
• Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia.
• Pregnant or lactating women.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Stomatitis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Study Officials

• Jian Guan, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan, MD

CONTACT

+86-13632102247; 51643930@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: October 31, 2023
• Primary Completion: February 15, 2026
• Study Completion: February 28, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)