Back to resultsDoxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Primary Purpose
Swallowing-induced Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
doxepin solution
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Swallowing-induced Pain focused on measuring Nasopharyngeal carcinoma, Oral mucositis, Radiotherapy, Swallowing-induced pain, Doxepin
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Southern medical university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
doxepin solution
placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total Drowsiness Increase
The total drowsiness increase was measured by the numerical analogue scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Total Taste of the Agent
The total taste of the agent was measured by the numerical analogue scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Total Stinging or Burning From the Agent
The stinging or burning of the oral cavity/oropharynx was measured by the numerical analogue scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Difficulty in Swallowing Different Food
The difficulty in swallowing liquids, pureed food and solid food was measured respectively by the numerical analogue scale of 0 to 10, with 0=not at all and 10=very much in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Patient Preference for Continuing Therapy With the Agent
Patients were asked if they would like to continue treatment with that particular agent at 60 minutes after assigned administration.
Adverse Event Profiles
Adverse events were assessed and record using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Full Information
NCT ID
NCT06017895
First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06017895
Brief Title
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing-induced Pain
Keywords
Nasopharyngeal carcinoma, Oral mucositis, Radiotherapy, Swallowing-induced pain, Doxepin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doxepin solution
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
doxepin solution
Intervention Description
2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2.0 mL placebo sprayed to the posterior pharyngeal wall
Primary Outcome Measure Information:
Title
Redution of swallowing-induced pain
Description
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.
Time Frame
Baseline, and 10, 20, 30, 60 minutes after administration
Secondary Outcome Measure Information:
Title
Total Drowsiness Increase
Description
The total drowsiness increase was measured by the numerical analogue scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Time Frame
Baseline, and 10, 20, 30, 60 minutes after administration
Title
Total Taste of the Agent
Description
The total taste of the agent was measured by the numerical analogue scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Time Frame
10, 20, 30 and 60 minutes after administration
Title
Total Stinging or Burning From the Agent
Description
The stinging or burning of the oral cavity/oropharynx was measured by the numerical analogue scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Time Frame
10, 20, 30 and 60 minutes after administration
Title
Difficulty in Swallowing Different Food
Description
The difficulty in swallowing liquids, pureed food and solid food was measured respectively by the numerical analogue scale of 0 to 10, with 0=not at all and 10=very much in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Time Frame
Baseline, and 10, 20, 30, 60 minutes after administration
Title
Patient Preference for Continuing Therapy With the Agent
Description
Patients were asked if they would like to continue treatment with that particular agent at 60 minutes after assigned administration.
Time Frame
60 minutes after administration
Title
Adverse Event Profiles
Description
Adverse events were assessed and record using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Time Frame
up to one day after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Guan, Ph.D.
Phone
+86-13632102247
Email
51643930@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Guan, Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern medical university
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
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