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Trial Title:
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
NCT ID:
NCT06017895
Condition:
Swallowing-induced Pain
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Breakthrough Pain
Doxepin
Conditions: Keywords:
Nasopharyngeal carcinoma
Oral mucositis
Radiotherapy
Swallowing-induced pain
Doxepin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
doxepin solution
Description:
2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
Arm group label:
doxepin solution
Intervention type:
Other
Intervention name:
Placebo
Description:
2.0 mL placebo sprayed to the posterior pharyngeal wall
Arm group label:
placebo
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.
Detailed description:
Patients with nasopharyngeal carcinoma receiving radical radiotherapy or
chemoradiotherapy who developed oral mucositis and had a swallowing-induced pain score ≥
4 were recruited and randomly assigned 1:1 to the experimental group and the control
group.
Patients in the experimental group 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.
Patients in the control group 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.
The swallowing-induced pain and incidence of adverse events were assessed at 10 minutes,
20 minutes, 30 minutes, and 1 hour after medication using a patient-reported
questionnaire, and safety evaluation was conducted 1 day after treatment.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, Ph.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, Ph.D.
Email:
Principal Investigator
Start date:
November 1, 2023
Completion date:
September 15, 2024
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06017895
