<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/NCT04440930</url>
  </required_header>
  <id_info>
    <org_study_id>WHITE TEA</org_study_id>
    <nct_id>NCT04440930</nct_id>
  </id_info>
  <brief_title>White Tea for Prevention of Chemotherapy Induced Mucositis</brief_title>
  <official_title>Can White Tea Prevent Oral Mucositis in Patients Receiving Neoadjuvant or Adjuvant Treatment With Paclitaxel for Breast Cancer? A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vejle Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the effectiveness of mouthwash with white tea in the&#xD;
      prevention of paclitaxel induced oral mucositis in women with breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral mucositis is a common side effect from paclitaxel treatment. It can be very painful and&#xD;
      compromise nutrition and oral hygiene, and it may increase the risk of infection. Although&#xD;
      oral mucositis is a common side effect to chemotherapy, no available treatment is yet&#xD;
      available that can effectively prevent or treat oral mucositis.&#xD;
&#xD;
      Based on the knowledge that white tea has anti-inflammatory, anti-oxidant and anti-microbial&#xD;
      effect, the current study aims to assess the effect of mouth wash with white tea on&#xD;
      paclitaxel induced oral mucositis in women with breast cancer.&#xD;
&#xD;
      This study is a phase II randomized controlled trial in which eligible patients will be&#xD;
      allocated to a control group (CG) and a study group (SG). The CG will use salt water with&#xD;
      soda for mouthwash eight to ten times a day and the SG will use white tea for mouthwash five&#xD;
      to six times a day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">March 28, 2023</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.</measure>
    <time_frame>up to nine weeks</time_frame>
    <description>Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of daily mouthwashes</measure>
    <time_frame>once a week over a period of nine weeks</time_frame>
    <description>Number of daily mouthwashes will be registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of daily tooth brushings</measure>
    <time_frame>once a week over a period of nine weeks</time_frame>
    <description>Number of daily tooth brushings will be registered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS).</measure>
    <time_frame>Once a week over a period of nine weeks</time_frame>
    <description>Numeric Rating Scale 0-10; 0=no pain, 10=worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide.</measure>
    <time_frame>Once a week until oral mucositis occurs up to nine weeks</time_frame>
    <description>Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Oral Mucositis</condition>
  <arm_group>
    <arm_group_label>White tea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Salt water with soda</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White tea</intervention_name>
    <description>Mouthwash with white tea five to six times a day for nine weeks</description>
    <arm_group_label>White tea</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Salt water with soda</intervention_name>
    <description>Mouthwash with salt water and soda eight to ten times a day for nine weeks</description>
    <arm_group_label>Salt water with soda</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman with breast cancer&#xD;
&#xD;
          -  Planned neoadjuvant or adjuvant paclitaxel treatment&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Understand and speak Danish&#xD;
&#xD;
          -  Written and orally informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Palliative treatment with paclitaxel&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erik H Jakobsen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mucositis</keyword>
  <keyword>mouth</keyword>
  <keyword>paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Stomatitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04440930
org study id: WHITE TEA
nct id: NCT04440930
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the effectiveness of mouthwash with white tea in the
      prevention of paclitaxel induced oral mucositis in women with breast cancer.
Oral mucositis is a common side effect from paclitaxel treatment. It can be very painful and
      compromise nutrition and oral hygiene, and it may increase the risk of infection. Although
      oral mucositis is a common side effect to chemotherapy, no available treatment is yet
      available that can effectively prevent or treat oral mucositis.

      Based on the knowledge that white tea has anti-inflammatory, anti-oxidant and anti-microbial
      effect, the current study aims to assess the effect of mouth wash with white tea on
      paclitaxel induced oral mucositis in women with breast cancer.

      This study is a phase II randomized controlled trial in which eligible patients will be
      allocated to a control group (CG) and a study group (SG). The CG will use salt water with
      soda for mouthwash eight to ten times a day and the SG will use white tea for mouthwash five
      to six times a day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.
time frame: up to nine weeks
description: Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems).
measure: Frequency of daily mouthwashes
time frame: once a week over a period of nine weeks
description: Number of daily mouthwashes will be registered
measure: Frequency of daily tooth brushings
time frame: once a week over a period of nine weeks
description: Number of daily tooth brushings will be registered
measure: Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS).
time frame: Once a week over a period of nine weeks
description: Numeric Rating Scale 0-10; 0=no pain, 10=worst possible pain
measure: Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide.
time frame: Once a week until oral mucositis occurs up to nine weeks
description: Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems).
arm group label: White tea
arm group type: Experimental
arm group label: Salt water with soda
arm group type: Active Comparator
intervention type: Other
intervention name: White tea
description: Mouthwash with white tea five to six times a day for nine weeks
arm group label: White tea
intervention type: Other
intervention name: Salt water with soda
description: Mouthwash with salt water and soda eight to ten times a day for nine weeks
arm group label: Salt water with soda
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erik H Jakobsen, MD
role: Study Chair
affiliation: Vejle Hospital
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Mucositis
mesh term: Stomatitis