<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/NCT01668849</url>
  </required_header>
  <id_info>
    <org_study_id>12.0220</org_study_id>
    <nct_id>NCT01668849</nct_id>
  </id_info>
  <brief_title>Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer</brief_title>
  <official_title>Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James Graham Brown Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the ability of grape exosomes, given to the subject as grape powder,&#xD;
      as an important anti-inflammatory agent to reduce the incidence of oral mucositis during&#xD;
      radiation and chemotherapy treatment for head and neck tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent&#xD;
      oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be&#xD;
      evaluated is the effect of grape exosomes on the production of cytokines and immune responses&#xD;
      to tumor exosomal antigens, metabolic and molecular markers in these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2012</start_date>
  <completion_date type="Actual">June 3, 2022</completion_date>
  <primary_completion_date type="Actual">May 25, 2022</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain caused by oral mucositis</measure>
    <time_frame>Total followup of six months</time_frame>
    <description>Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of immune biomarkers in blood</measure>
    <time_frame>Within three days of the completion of radiation therapy which will last approximately 30 days.</time_frame>
    <description>Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of immune biomarkers in mucosal tissue</measure>
    <time_frame>Within three days of the completion of radiation therapy which will last approximately thirty days.</time_frame>
    <description>Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Oral Mucositis</condition>
  <arm_group>
    <arm_group_label>1 - Grape extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 - Lortab, Fentanyl patch, mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Grape extract</intervention_name>
    <description>Grape extract self-administered by mouth daily for 35 days</description>
    <arm_group_label>1 - Grape extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lortab, Fentanyl patch, mouthwash</intervention_name>
    <description>Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash</description>
    <arm_group_label>2 - Lortab, Fentanyl patch, mouthwash</arm_group_label>
    <other_name>Lortab 5-10 mg</other_name>
    <other_name>Fentanyl patch 25 mcgs</other_name>
    <other_name>Mary's Magic Mouthwash</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have definitive diagnosis of head and neck cancer.&#xD;
&#xD;
          -  Concurrent chemoradiation treatment of the primary tumor must be an option for the&#xD;
             newly diagnosed cancer.&#xD;
&#xD;
          -  Patients must be informed of the investigational nature of this study and sign and&#xD;
             give written informed consent in accordance with institutional and federal guidelines.&#xD;
&#xD;
          -  Absence of life limiting medical conditions&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
          -  ECOG performance status 0, 1, or 2 (Karnofsky &gt; 60%).&#xD;
&#xD;
          -  Patients must have adequate bone marrow function. ANC &gt; 1000/microL and Platelet count&#xD;
             &gt;100,000/microL&#xD;
&#xD;
          -  Age &gt;20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known familial head and neck cancer syndrome&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known HIV&#xD;
&#xD;
          -  Patients receiving immunosuppressive drugs&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Active second malignancy in the last 5 years&#xD;
&#xD;
          -  Patients receiving any other investigational agent(s)&#xD;
&#xD;
          -  Patients who have received any prior chemotherapy or radiation therapy to the primary&#xD;
             head and neck cancer&#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>Rebecca Redman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>James Graham Brown Cancer Center, University of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James Graham Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.browncancercenter.org</url>
    <description>James Graham Brown Cancer Center, Louisville, Kentucky</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Rebecca Redman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Plant exosomes</keyword>
  <keyword>Grape exosomes</keyword>
  <keyword>Grape extract</keyword>
  <keyword>Oral mucositis</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Immune response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <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>Acetaminophen, hydrocodone drug combination</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
  </intervention_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/NCT01668849
org study id: 12.0220
nct id: NCT01668849
lead sponsor: 
collaborator: 
has dmc: Yes
This study will evaluate the ability of grape exosomes, given to the subject as grape powder,
      as an important anti-inflammatory agent to reduce the incidence of oral mucositis during
      radiation and chemotherapy treatment for head and neck tumors.
The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent
      oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be
      evaluated is the effect of grape exosomes on the production of cytokines and immune responses
      to tumor exosomal antigens, metabolic and molecular markers in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain caused by oral mucositis
time frame: Total followup of six months
description: Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
measure: Level of immune biomarkers in blood
time frame: Within three days of the completion of radiation therapy which will last approximately 30 days.
description: Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.
measure: Level of immune biomarkers in mucosal tissue
time frame: Within three days of the completion of radiation therapy which will last approximately thirty days.
description: Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.
arm group label: 1 - Grape extract
arm group type: Experimental
description: Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
arm group label: 2 - Lortab, Fentanyl patch, mouthwash
arm group type: Active Comparator
description: Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
intervention type: Dietary Supplement
intervention name: Grape extract
description: Grape extract self-administered by mouth daily for 35 days
arm group label: 1 - Grape extract
intervention type: Drug
intervention name: Lortab, Fentanyl patch, mouthwash
description: Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
arm group label: 2 - Lortab, Fentanyl patch, mouthwash
other name: Lortab 5-10 mg
other name: Fentanyl patch 25 mcgs
other name: Mary's Magic Mouthwash
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rebecca Redman, MD
role: Principal Investigator
affiliation: James Graham Brown Cancer Center, University of Louisville
facility: 
country: United States
url: http://www.browncancercenter.org
description: James Graham Brown Cancer Center, Louisville, Kentucky
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Rebecca Redman
investigator title: Associate Professor
mesh term: Head and Neck Neoplasms
mesh term: Mucositis
mesh term: Stomatitis
mesh term: Acetaminophen, hydrocodone drug combination
mesh term: Fentanyl