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/NCT05994638</url>
    </required_header>
    <id_info>
      <org_study_id>08-AP-ONCOS</org_study_id>
      <nct_id>NCT05994638</nct_id>
    </id_info>
    <brief_title>Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy</brief_title>
    <official_title>Polyphenol Rich Aerosol as a Support for Cancer Patients in Minimizing Side Effects After a Radiation Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</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 the study is to demonstrate in a clinical condition the effectiveness of a&#xD;
        preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect&#xD;
        of supporting cancer patients in minimizing side effects after a radiation therapy cycle.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted on a group of 10 patients with head and neck cancer who have&#xD;
        undergone radiation therapy and experience side effects such as discomfort/changes in the&#xD;
        oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before&#xD;
        and after the study, an assessment questionnaire related to the side effects of radiation&#xD;
        therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Side effects after radiotherapy</measure>
      <time_frame>Baseline, 1 month</time_frame>
      <description>Based on a questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Impact of dysphagia on quality of life</measure>
      <time_frame>Baseline, 1 month</time_frame>
      <description>Based on a MDADI questionnaire</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Oral Mucositis</condition>
    <arm_group>
      <arm_group_label>Aerosol for use in the oral cavity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of 10 patients with head and neck cancer who have undergone radiotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)</intervention_name>
      <description>Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3</description>
      <arm_group_label>Aerosol for use in the oral cavity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 18-75 years old&#xD;
  &#xD;
            -  Patients with head and neck cancer or other types of cancer after radiotherapy who&#xD;
               suffer from oral mucositis&#xD;
  &#xD;
            -  Patients with dryness in mouth&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins&#xD;
  &#xD;
            -  Participation in another clinical trial,&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study or breastfeeding,&#xD;
  &#xD;
            -  Autoimmune disease, severe liver dysfunction, inflammatory bowel disease,&#xD;
               tuberculosis, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation.&#xD;
  &#xD;
            -  Hypersensitivity/allergy to any of the ingredient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Uniwersyteckie Centrum Stomatologiczne GUMed</name>
        <address>
          <city>Gdańsk</city>
          <zip>80-204</zip>
          <country>Poland</country>
        </address>
      </facility>
      <contact>
        <last_name>Barbara Khaidakov, PhD</last_name>
        <phone>798 210 651</phone>
        <phone_ext>+48</phone_ext>
        <email>barbara.khaidakov@aronpharma.pl</email>
      </contact>
      <investigator>
        <last_name>Iwona Ordyniec-Kwaśnica, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Radiotherapy</keyword>
    <keyword>Head and neck cancer</keyword>
    <keyword>Dysphagia</keyword>
    <keyword>Oral Mucositis</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Niacinamide</mesh_term>
      <mesh_term>Hyaluronic Acid</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/NCT05994638
  org study id: 08-AP-ONCOS
  nct id: NCT05994638
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to demonstrate in a clinical condition the effectiveness of a
        preparation that is a mixture of plant extracts rich in polyphenolic compounds in the aspect
        of supporting cancer patients in minimizing side effects after a radiation therapy cycle.
  The study will be conducted on a group of 10 patients with head and neck cancer who have
        undergone radiation therapy and experience side effects such as discomfort/changes in the
        oral mucosa.The patients will receive an aerosol for oral use for a period of 1 month. Before
        and after the study, an assessment questionnaire related to the side effects of radiation
        therapy will be conducted, along with the MD Anderson Dysphagia Inventory questionnaire.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Side effects after radiotherapy
  time frame: Baseline, 1 month
  description: Based on a questionnaire
  measure: Impact of dysphagia on quality of life
  time frame: Baseline, 1 month
  description: Based on a MDADI questionnaire
  arm group label: Aerosol for use in the oral cavity
  arm group type: Experimental
  description: Group of 10 patients with head and neck cancer who have undergone radiotherapy
  intervention type: Dietary Supplement
  intervention name: Aerosol (Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3)
  description: Polyphenol-rich plant extracts, Hyaluronic Acid, Cetraria Islandica, Vitamin B3
  arm group label: Aerosol for use in the oral cavity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  investigator: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Mucositis
  mesh term: Stomatitis
  mesh term: Niacinamide
  mesh term: Hyaluronic Acid
  sharing ipd: No