xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017895</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2023-351</org_study_id>
      <nct_id>NCT06017895</nct_id>
    </id_info>
    <brief_title>Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanfang Hospital, Southern Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to explore the effectiveness and adverse reactions of&#xD;
        doxepin solution spray for alleviation of stubborn breakthrough pain induced by swallowing in&#xD;
        patients receiving radiotherapy for nasopharyngeal carcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy&#xD;
        who developed oral mucositis and had a swallowing-induced pain score ≥ 4 were recruited and&#xD;
        randomly assigned 1:1 to the experimental group and the control group.&#xD;
  &#xD;
        Patients in the experimental group received a doxepin solution spray to the posterior&#xD;
        pharyngeal wall 10 minutes before eating. At least 12 hours later, when the&#xD;
        swallowing-induced pain score ≥4, a placebo spray was administered to the posterior&#xD;
        pharyngeal wall 10 minutes before eating.&#xD;
  &#xD;
        Patients in the control group received a placebo spray to the posterior pharyngeal wall 10&#xD;
        minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a&#xD;
        doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before&#xD;
        eating.&#xD;
  &#xD;
        The swallowing-induced pain and incidence of adverse events were assessed at 10 minutes, 20&#xD;
        minutes, 30 minutes, and 1 hour after medication using a patient-reported questionnaire, and&#xD;
        safety evaluation was conducted 1 day after treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Redution of swallowing-induced pain</measure>
      <time_frame>Baseline, and 10, 20, 30, 60 minutes after administration</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total Drowsiness Increase</measure>
      <time_frame>Baseline, and 10, 20, 30, 60 minutes after administration</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Taste of the Agent</measure>
      <time_frame>10, 20, 30 and 60 minutes after administration</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Stinging or Burning From the Agent</measure>
      <time_frame>10, 20, 30 and 60 minutes after administration</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulty in Swallowing Different Food</measure>
      <time_frame>Baseline, and 10, 20, 30, 60 minutes after administration</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Preference for Continuing Therapy With the Agent</measure>
      <time_frame>60 minutes after administration</time_frame>
      <description>Patients were asked if they would like to continue treatment with that particular agent at 60 minutes after assigned administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Event Profiles</measure>
      <time_frame>up to one day after administration</time_frame>
      <description>Adverse events were assessed and record using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">178</enrollment>
    <condition>Swallowing-induced Pain</condition>
    <arm_group>
      <arm_group_label>doxepin solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>doxepin solution</intervention_name>
      <description>2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall</description>
      <arm_group_label>doxepin solution</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>2.0 mL placebo sprayed to the posterior pharyngeal wall</description>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provide informed written consent.&#xD;
  &#xD;
            2. Age ≥ 18 years.&#xD;
  &#xD;
            3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical&#xD;
               radiotherapy or chemoradiotherapy.&#xD;
  &#xD;
            4. Physical examination demonstrating the presence of radiation-induced mucositis in the&#xD;
               oral cavity and/or oropharynx.&#xD;
  &#xD;
            5. At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the&#xD;
               numeric rating scale of pain.&#xD;
  &#xD;
            6. Being able to complete the questionnaires independently or with assistance.&#xD;
  &#xD;
            7. ECOG Performance Status 0, 1 or 2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the&#xD;
               drug formulation.&#xD;
  &#xD;
            2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior&#xD;
               to registration.&#xD;
  &#xD;
            3. Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection.&#xD;
  &#xD;
            4. Untreated narrow angle glaucoma within 6 weeks prior to registration.&#xD;
  &#xD;
            5. Untreated urinary retention within 6 weeks prior to registration.&#xD;
  &#xD;
            6. Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to&#xD;
               registration.&#xD;
  &#xD;
            7. Current serious heart disease or a recent history of myocardial infarction.&#xD;
  &#xD;
            8. Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic&#xD;
               dysfunction, delirium, and neutropenia.&#xD;
  &#xD;
            9. Pregnant or lactating women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jian Guan, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian Guan, Ph.D.</last_name>
      <phone>+86-13632102247</phone>
      <email>51643930@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Southern medical university</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510515</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nasopharyngeal carcinoma</keyword>
    <keyword>Oral mucositis</keyword>
    <keyword>Radiotherapy</keyword>
    <keyword>Swallowing-induced pain</keyword>
    <keyword>Doxepin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
      <mesh_term>Breakthrough Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Doxepin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017895
  org study id: NFEC-2023-351
  nct id: NCT06017895
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Redution of swallowing-induced pain
  time frame: Baseline, and 10, 20, 30, 60 minutes after administration
  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.
  measure: Total Drowsiness Increase
  time frame: Baseline, and 10, 20, 30, 60 minutes after administration
  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.
  measure: Total Taste of the Agent
  time frame: 10, 20, 30 and 60 minutes after administration
  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.
  measure: Total Stinging or Burning From the Agent
  time frame: 10, 20, 30 and 60 minutes after administration
  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.
  measure: Difficulty in Swallowing Different Food
  time frame: Baseline, and 10, 20, 30, 60 minutes after administration
  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.
  measure: Patient Preference for Continuing Therapy With the Agent
  time frame: 60 minutes after administration
  description: Patients were asked if they would like to continue treatment with that particular agent at 60 minutes after assigned administration.
  measure: Adverse Event Profiles
  time frame: up to one day after administration
  description: Adverse events were assessed and record using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
  arm group label: doxepin solution
  arm group type: Experimental
  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 group label: placebo
  arm group type: Placebo Comparator
  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: 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
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jian Guan, Ph.D.
  role: Principal Investigator
  affiliation: Nanfang Hospital, Southern Medical University
  last name: Jian Guan, Ph.D.
  phone: +86-13632102247
  email: 51643930@qq.com
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma
  mesh term: Breakthrough Pain
  mesh term: Doxepin
  sharing ipd: No