<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/NCT04491435</url>
  </required_header>
  <id_info>
    <org_study_id>FF2018-133</org_study_id>
    <nct_id>NCT04491435</nct_id>
  </id_info>
  <brief_title>Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial</brief_title>
  <official_title>Saliva Substitute Mouthwash in NPC Survivors With Xerostomia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy&#xD;
      reported in Malaysia affecting predominantly male adults between 40-60 years old [1, 2].&#xD;
      Radiation therapy (RT) has been coined as the mainstay treatment owing to its' radiosensitive&#xD;
      properties [1, 3]. Radiation-induced DNA damage impairs proper cell division, resulting in&#xD;
      cell death or senescence of cells that attempt to divide, particularly useful in killing&#xD;
      malignant cells. However, radiation doses to the salivary glands cause loss of saliva&#xD;
      producing acinar cells which ultimately hampers production of saliva in NPC patients post&#xD;
      radiation [4]. This leads to progressive loss of salivary gland function causing xerostomia&#xD;
      symptoms [5]. This study aims to compare the effects of two mouthwashes in the treatment of&#xD;
      xerostomia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Xerostomia, or dry mouth caused by reduced or absent saliva flow, is a subjective symptom&#xD;
      that can lead to impaired chewing, swallowing, altered sense of taste and speech. This&#xD;
      eventually affects their nutritional status and quality of life. The reported prevalence of&#xD;
      xerostomia in NPC survivors ranged from 80% -100% [6-9]. This high prevalence has stemmed a&#xD;
      lot of interest in prevention and treatment of this important sequelae. Saliva substitute in&#xD;
      the forms of gels, toothpaste, sprays or mouthwash has been used for treatment of xerostomia&#xD;
      [10]. Oral7® mouthwash (Oral7 International, United Kingdom) is a mucin-based saliva&#xD;
      substitute formulated with natural enzymes such as lactoperoxidase, lysozyme, glucose oxidase&#xD;
      and lactoferrin, similar to naturally occuring saliva. The biophysical properties of the&#xD;
      mouthwash can potentially provide relief to xerostomia symptoms in patients post radiotherapy&#xD;
      translating to a better quality of life. Hence, the purpose of the present study is to&#xD;
      evaluate the effects of saliva substitute in treating xerostomia among NPC patients post&#xD;
      radiotherapy. The primary end-point of the study was to compare the subjective xerostomia&#xD;
      symptoms, measured using a validated inventory taken 4 weeks following intervention and at&#xD;
      baseline between patients who did not receive and patients who received Oral7® mouthwash. The&#xD;
      secondary end-point was to demonstrate similar changes in objective measurements using&#xD;
      sialometry techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2018</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">January 5, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants and outcome assessor blinded to allocation of treatment, which was only revealed after completion of data collection</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>summated xerostomia inventory (SXI) score</measure>
    <time_frame>4 weeks</time_frame>
    <description>summated xerostomia inventory (SXI) score at baseline-summated xerostomia inventory (SXI) score at 4 weeks post intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>unstimulated whole saliva (UWS) flow</measure>
    <time_frame>4 weeks</time_frame>
    <description>unstimulated whole saliva (UWS) flow at 4 weeks post intervention -unstimulated whole saliva (UWS) flow at baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Xerostomia, Hyposalivation, Saliva Substitute, Radiation-induced Toxicity, Nasopharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks use of mucin-based saliva substitute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 weeks use of xylitol-based mouthwash</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Summated Xerostomia Inventory</intervention_name>
    <description>structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI)</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sialometry</intervention_name>
    <description>unstimulated whole saliva (UWS) flow measurement</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have completed radiation therapy or concurrent chemotherapy and radiation&#xD;
             therapy for nasopharyngeal carcinoma (clinical staging of tumour based on AJCC staging&#xD;
             (8th edition) T1-4, N0-3, M0).&#xD;
&#xD;
          -  Patients age 20 years old to 85 years old.&#xD;
&#xD;
          -  Two months has elapsed since last dose of chemotherapy or radiotherapy&#xD;
&#xD;
          -  Karnofsky performance score more than 70%.&#xD;
&#xD;
          -  Patients complaining of xerostomia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those contraindicated to using mouthwash (established allergy to lactoperoxidase,&#xD;
             lysozyme, glucose oxidase lactoferrin, cetylpyridinium chloride and xylitol)&#xD;
&#xD;
          -  Patients with residual or recurrent disease.&#xD;
&#xD;
          -  Patients who received intensity modulated radiation therapy.&#xD;
&#xD;
          -  Patients with ongoing oral mucositis (WHO Oral Mucositis grading I to IV)&#xD;
&#xD;
          -  Patients with facial, glossopharyngeal. vagus and hypoglossal nerve palsy/ paresis.&#xD;
&#xD;
          -  Patients who had any form of concurrent treatment protocols (hormonal, alternative,&#xD;
             antiviral, sialogogues or photodynamic therapy) during the study duration.&#xD;
&#xD;
          -  Patients with autoimmune diseases such as systemic lupus erythematosus, rheumatoid&#xD;
             arthritis and Sjớgren syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mawaddah Azman, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universiti Kebangsaan Malaysia Medical Centre</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Gravenmade EJ, Vissink A. Mucin-containing lozenges in the treatment of intraoral problems associated with Sjogren's syndrome. A double-blind crossover study in 42 patients. Oral Surg Oral Med Oral Pathol. 1993 Apr;75(4):466-71. doi: 10.1016/0030-4220(93)90172-z.</citation>
    <PMID>8464611</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Xerostomia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be shared upon publication of the research</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491435
org study id: FF2018-133
nct id: NCT04491435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Nasopharyngeal carcinoma (NPC) is the highest reported otorhinolaryngological malignancy
      reported in Malaysia affecting predominantly male adults between 40-60 years old [1, 2].
      Radiation therapy (RT) has been coined as the mainstay treatment owing to its' radiosensitive
      properties [1, 3]. Radiation-induced DNA damage impairs proper cell division, resulting in
      cell death or senescence of cells that attempt to divide, particularly useful in killing
      malignant cells. However, radiation doses to the salivary glands cause loss of saliva
      producing acinar cells which ultimately hampers production of saliva in NPC patients post
      radiation [4]. This leads to progressive loss of salivary gland function causing xerostomia
      symptoms [5]. This study aims to compare the effects of two mouthwashes in the treatment of
      xerostomia.
Xerostomia, or dry mouth caused by reduced or absent saliva flow, is a subjective symptom
      that can lead to impaired chewing, swallowing, altered sense of taste and speech. This
      eventually affects their nutritional status and quality of life. The reported prevalence of
      xerostomia in NPC survivors ranged from 80% -100% [6-9]. This high prevalence has stemmed a
      lot of interest in prevention and treatment of this important sequelae. Saliva substitute in
      the forms of gels, toothpaste, sprays or mouthwash has been used for treatment of xerostomia
      [10]. Oral7® mouthwash (Oral7 International, United Kingdom) is a mucin-based saliva
      substitute formulated with natural enzymes such as lactoperoxidase, lysozyme, glucose oxidase
      and lactoferrin, similar to naturally occuring saliva. The biophysical properties of the
      mouthwash can potentially provide relief to xerostomia symptoms in patients post radiotherapy
      translating to a better quality of life. Hence, the purpose of the present study is to
      evaluate the effects of saliva substitute in treating xerostomia among NPC patients post
      radiotherapy. The primary end-point of the study was to compare the subjective xerostomia
      symptoms, measured using a validated inventory taken 4 weeks following intervention and at
      baseline between patients who did not receive and patients who received Oral7® mouthwash. The
      secondary end-point was to demonstrate similar changes in objective measurements using
      sialometry techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: Participants and outcome assessor blinded to allocation of treatment, which was only revealed after completion of data collection
measure: summated xerostomia inventory (SXI) score
time frame: 4 weeks
description: summated xerostomia inventory (SXI) score at baseline-summated xerostomia inventory (SXI) score at 4 weeks post intervention
measure: unstimulated whole saliva (UWS) flow
time frame: 4 weeks
description: unstimulated whole saliva (UWS) flow at 4 weeks post intervention -unstimulated whole saliva (UWS) flow at baseline
arm group label: Interventional
arm group type: Experimental
description: 4 weeks use of mucin-based saliva substitute
arm group label: Control
arm group type: Placebo Comparator
description: 4 weeks use of xylitol-based mouthwash
intervention type: Diagnostic Test
intervention name: Summated Xerostomia Inventory
description: structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI)
arm group label: Control
arm group label: Interventional
intervention type: Diagnostic Test
intervention name: Sialometry
description: unstimulated whole saliva (UWS) flow measurement
arm group label: Control
arm group label: Interventional
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mawaddah Azman, MS
role: Principal Investigator
affiliation: National University of Malaysia
facility: 
country: Malaysia
citation: Gravenmade EJ, Vissink A. Mucin-containing lozenges in the treatment of intraoral problems associated with Sjogren's syndrome. A double-blind crossover study in 42 patients. Oral Surg Oral Med Oral Pathol. 1993 Apr;75(4):466-71. doi: 10.1016/0030-4220(93)90172-z.
PMID: 8464611
responsible party type: Sponsor
mesh term: Nasopharyngeal Neoplasms
mesh term: Nasopharyngeal Carcinoma
mesh term: Xerostomia
sharing ipd: No
ipd description: IPD will be shared upon publication of the research