<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/NCT01732393</url>
  </required_header>
  <id_info>
    <org_study_id>89470</org_study_id>
    <nct_id>NCT01732393</nct_id>
  </id_info>
  <brief_title>Effect of Quercetin in Prevention and Treatment of Oral Mucositis</brief_title>
  <official_title>Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and&#xD;
      treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>lower grade of mucositis</measure>
    <time_frame>3 weeks</time_frame>
    <description>grade of mucositis due to WHO criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of mucositis</measure>
    <time_frame>3 weeks of study tiem span and after trial</time_frame>
    <description>duration of mucositis due to Who criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Chemotherapy Induced Oral Mucositis</condition>
  <arm_group>
    <arm_group_label>oral quercetin capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oral placebo capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in the placebo group received two placebo capsules containing lactose .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral quercetin capsules</intervention_name>
    <description>10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.</description>
    <arm_group_label>oral quercetin capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>oral placebo capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient under chemotherapy&#xD;
&#xD;
          -  for a hematologic malignancy&#xD;
&#xD;
          -  the hematologist permits the trial on the patient&#xD;
&#xD;
          -  agreement of patient for participating in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence pf ANY oral lesion at the beginning of the trial&#xD;
&#xD;
          -  loss of follow up&#xD;
&#xD;
          -  use of digoxin and cyclosporine&#xD;
&#xD;
          -  patient death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pegah Mosannen Mozafari, assistant professor</last_name>
    <role>Study Director</role>
    <affiliation>Mashhad University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oral Medicine Department of Mashhad dental School</name>
      <address>
        <city>MAshhad</city>
        <state>Khorasan Razavi</state>
        <zip>91735-498</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>December 4, 2012</last_update_submitted>
  <last_update_submitted_qc>December 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Pegah Mosannen Mozafari</investigator_full_name>
    <investigator_title>assistant professor of oral medicine</investigator_title>
  </responsible_party>
  <keyword>Quercetin</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Mucositis</keyword>
  <keyword>Hematologic Malignancies</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>Quercetin</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/NCT01732393
org study id: 89470
nct id: NCT01732393
lead sponsor: 
has dmc: Yes
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and
      treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: lower grade of mucositis
time frame: 3 weeks
description: grade of mucositis due to WHO criteria
measure: duration of mucositis
time frame: 3 weeks of study tiem span and after trial
description: duration of mucositis due to Who criteria
arm group label: oral quercetin capsules
arm group type: Active Comparator
description: Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks
arm group label: oral placebo capsules
arm group type: Placebo Comparator
description: Patients in the placebo group received two placebo capsules containing lactose .
intervention type: Drug
intervention name: oral quercetin capsules
description: 10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
arm group label: oral quercetin capsules
intervention type: Drug
intervention name: Placebo
arm group label: oral placebo capsules
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: No
last name: Pegah Mosannen Mozafari, assistant professor
role: Study Director
affiliation: Mashhad University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Pegah Mosannen Mozafari
investigator title: assistant professor of oral medicine
mesh term: Mucositis
mesh term: Stomatitis
mesh term: Quercetin