<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/NCT02989129</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0287</org_study_id>
    <nct_id>NCT02989129</nct_id>
  </id_info>
  <brief_title>Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients</brief_title>
  <official_title>Prospective Open Labeled Pilot Trial of Quercetin in the Treatment and Prevention of Chemotherapy-induced Neuropathic Pain in Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn about the effectiveness of quercetin in&#xD;
      treating and preventing CINP. Researchers also want to learn if quercetin has an effect on&#xD;
      participant's quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Product Administration:&#xD;
&#xD;
      If participant is found to be eligible to take part in this study, participant will take&#xD;
      quercetin tablets by mouth 2 times every day for 12 weeks. The study staff will give&#xD;
      participant the tablets and additional instructions on how to take the study product.&#xD;
&#xD;
      Length of Participation:&#xD;
&#xD;
      Participant may take quercetin for up to 12 weeks. Participant will no longer be able to take&#xD;
      quercetin if the pain symptoms gets worse, if intolerable side effects occur, or if&#xD;
      participant is unable to follow study directions.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      Every week, participant will either come to the clinic or a member of the staff will call&#xD;
      participant to learn how participant is doing, if participant has had any side effects, and&#xD;
      to check that participant is taking quercetin correctly. Participant will also complete a&#xD;
      questionnaire about any pain symptoms participant may be having. The call/questionnaire&#xD;
      should take about 10-15 minutes to complete.&#xD;
&#xD;
      End-of-Study Visit:&#xD;
&#xD;
      About 7 days after participant's last dose of quercetin, participant will complete the same&#xD;
      questionnaires participant completed at screening.&#xD;
&#xD;
      Participation in this study will be over after the end-of-study visit.&#xD;
&#xD;
      This is an investigational study. Quercetin is commercially available as a supplement, but it&#xD;
      is not FDA approved.The study doctor can explain how the study product is designed to work.&#xD;
&#xD;
      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    FDA IND Approval&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Neuropathic Pain Intensity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Primary endpoint is the change in neuropathic pain intensity during 12 weeks of treatment using the the Douleur Neuropathique en 4 questions (DN4).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Polyneuropathies and Other Disorders of the Peripheral Nervous System</condition>
  <condition>Chemotherapy Induced Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaires completed at Baseline and at End of Study Visit.&#xD;
Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Questionnaires completed at Baseline and at End of Study Visit.&#xD;
Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires regarding quality of life, pain level, and related symptoms completed at Baseline and at End of Study Visit.. It should take less than 1 hour to complete these questionnaires.</description>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group</arm_group_label>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quercetin</intervention_name>
    <description>500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.</description>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group</arm_group_label>
    <arm_group_label>Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients &gt; 18 years old.&#xD;
&#xD;
          2. Patients starting, undergoing or completed chemotherapy at MD Anderson Cancer Center&#xD;
&#xD;
          3. Any cancer patients who received any of the chemotherapeutic agents listed below and&#xD;
             developed neuropathic pain for the treatment cohort; or any cancer patients who have&#xD;
             been scheduled to receive any of the chemotherapeutic agents listed below for the&#xD;
             preventive cohort. The chemotherapeutic agents include 1) taxanes (paclitaxel,&#xD;
             docetaxel), 2) vinca alkaloids (vincristine, vinblastine), 3) platinum agents&#xD;
             (cisplatin, carboplatin, oxaliplatin), and 4) others (thalidomide, bortezomib,&#xD;
             lenalidomide).&#xD;
&#xD;
          4. Patients have neuropathic pain intensity of at least 4/10 on numeric rating score&#xD;
             (NRS, 0/10 being no pain and 10/10 excruciating pain) for the treatment cohort; or&#xD;
             0/10 on NRS for the preventive cohort.&#xD;
&#xD;
          5. Patients are on stable dose of any medication&#xD;
&#xD;
          6. Patients followed at the Pain Medicine department. Patients with normal renal function&#xD;
             (Normal values, BUN (blood urea nitrogen): 8 to 20 mg/dL, Creatinine: 0.7 to 1.3&#xD;
             mg/dL).&#xD;
&#xD;
          7. Patients able to speak English.&#xD;
&#xD;
          8. Patients able to review, understand, and provide written consent.&#xD;
&#xD;
          9. Patients with an Eastern Cooperative Oncology performance (ECOG) status of 0-2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Renal impairment.&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
          3. Hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to&#xD;
             quercetin or product components.&#xD;
&#xD;
          4. Patients who are enrolled in another Pain Medicine trial.&#xD;
&#xD;
          5. Patients with malabsorption syndrome or resection of the stomach or small bowel.&#xD;
&#xD;
          6. Patients with any condition that precludes use of the study medication as determined&#xD;
             by the treating physician.&#xD;
&#xD;
          7. Patients taking Quercetin for other medical reasons.&#xD;
&#xD;
          8. Patients taking Digoxin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salahadin Abdi, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyneuropathies and Other Disorders of the Peripheral Nervous System</keyword>
  <keyword>Chemotherapy Induced Neuropathic Pain</keyword>
  <keyword>CINP</keyword>
  <keyword>Quercetin</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</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/NCT02989129
org study id: 2016-0287
nct id: NCT02989129
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn about the effectiveness of quercetin in
      treating and preventing CINP. Researchers also want to learn if quercetin has an effect on
      participant's quality of life.
Study Product Administration:

      If participant is found to be eligible to take part in this study, participant will take
      quercetin tablets by mouth 2 times every day for 12 weeks. The study staff will give
      participant the tablets and additional instructions on how to take the study product.

      Length of Participation:

      Participant may take quercetin for up to 12 weeks. Participant will no longer be able to take
      quercetin if the pain symptoms gets worse, if intolerable side effects occur, or if
      participant is unable to follow study directions.

      Study Visits:

      Every week, participant will either come to the clinic or a member of the staff will call
      participant to learn how participant is doing, if participant has had any side effects, and
      to check that participant is taking quercetin correctly. Participant will also complete a
      questionnaire about any pain symptoms participant may be having. The call/questionnaire
      should take about 10-15 minutes to complete.

      End-of-Study Visit:

      About 7 days after participant's last dose of quercetin, participant will complete the same
      questionnaires participant completed at screening.

      Participation in this study will be over after the end-of-study visit.

      This is an investigational study. Quercetin is commercially available as a supplement, but it
      is not FDA approved.The study doctor can explain how the study product is designed to work.

      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Neuropathic Pain Intensity
time frame: 12 weeks
description: Primary endpoint is the change in neuropathic pain intensity during 12 weeks of treatment using the the Douleur Neuropathique en 4 questions (DN4).
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group
arm group type: Experimental
description: Questionnaires completed at Baseline and at End of Study Visit.
Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group
arm group type: Experimental
description: Questionnaires completed at Baseline and at End of Study Visit.
Participants take Quercetin tablets by mouth 2 times every day for 12 weeks.
intervention type: Behavioral
intervention name: Questionnaires
description: Questionnaires regarding quality of life, pain level, and related symptoms completed at Baseline and at End of Study Visit.. It should take less than 1 hour to complete these questionnaires.
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group
other name: Surveys
intervention type: Drug
intervention name: Quercetin
description: 500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Prevention Group
arm group label: Chemotherapy Induced Neuropathic Pain (CINP) Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Salahadin Abdi, MD, PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Polyneuropathies
mesh term: Peripheral Nervous System Diseases
mesh term: Quercetin