<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/NCT01692210</url>
  </required_header>
  <id_info>
    <org_study_id>PA12-0524</org_study_id>
    <nct_id>NCT01692210</nct_id>
  </id_info>
  <brief_title>The Effect of Dexmedetomidine of the Immune System</brief_title>
  <official_title>The Effect of Dexmedetomidine on Immunological Parameters of Women Undergoing Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospira, now a wholly owned subsidiary of Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to learn about how dexmedetomidine (a standard of care&#xD;
      sedative) affects your immune system (your defenses against cancer) by measuring your white&#xD;
      blood cell levels before and after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used&#xD;
      to help lower the amount of pain killers and other anesthetics that are given to a patient&#xD;
      during surgery. Researchers want to study how this drug works in cancer patients and review&#xD;
      the patient's chart for pain levels and medication use after surgery. Part of this research&#xD;
      involves studying the immune system of surgery patients.&#xD;
&#xD;
      If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you&#xD;
      have surgery and the morning after surgery while you are still in the hospital. This blood&#xD;
      will be used to learn more about how your immune system works.&#xD;
&#xD;
      After your second blood draw, your participation in this study will be over.&#xD;
&#xD;
      This is an investigational study.&#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>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pre and Post Surgical Lymphocyte Counts</measure>
    <time_frame>2 days</time_frame>
    <description>Lymphocyte counts determined by flow-cytometry and their function by cytotoxicity assays performed in the laboratory using samples obtained before and the morning after surgery. Patients who experience a reduction of less than 50% of their preoperative natural killer cell (NKC) activity considered as a success.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Blood Draw Pre and Post Surgery</arm_group_label>
    <description>Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>After induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour.</description>
    <arm_group_label>Blood Draw Pre and Post Surgery</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      15cc of blood drawn prior or at the moment of anesthesia induction and the morning after&#xD;
      surgery.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center in&#xD;
        Houston, Texas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        3.1.1 - Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center.&#xD;
&#xD;
        3.1.2 - Patients 18 years of age and older. There will be no upper age restriction.&#xD;
&#xD;
        3.1.3 - Patients must sign a study-specific consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        3.2.1 - ASA 4&#xD;
&#xD;
        3.2.2 - Contraindication to the use of dexmedetomidine.&#xD;
&#xD;
        3.2.2.1. Decompensated congestive heart failure.&#xD;
&#xD;
        3.2.2.2. Second and third degree heart block.&#xD;
&#xD;
        3.2.2.2. Known allergy to dexmedetomidine or any of the medications used in the study&#xD;
&#xD;
        3.2.3 - Patients taking clonidine for treatment of arterial hypertension.&#xD;
&#xD;
        3.2.4 - Patients that are pregnant.&#xD;
&#xD;
        3.2.5 - Patients taking opioids at the time of surgery.&#xD;
&#xD;
        3.2.6 - Patients having plastic surgical reconstruction.&#xD;
&#xD;
        3.2.7 - Recent chemotherapy (&lt; 4 weeks).&#xD;
&#xD;
        3.2.8 - Active autoimmune or immunological disease including but not limited to systemic&#xD;
        lupus erythematous, rheumatoid arthritis and Sjogren's disease&#xD;
&#xD;
        3.2.9 - Patient refusal to participate in the study.&#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>Juan P. Cata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>January 5, 2016</last_update_submitted>
  <last_update_submitted_qc>January 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Unilateral mastectomy</keyword>
  <keyword>Blood sample collections</keyword>
  <keyword>Immune system</keyword>
  <keyword>White blood cell levels</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT01692210
org study id: PA12-0524
nct id: NCT01692210
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this research study is to learn about how dexmedetomidine (a standard of care
      sedative) affects your immune system (your defenses against cancer) by measuring your white
      blood cell levels before and after surgery.
Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used
      to help lower the amount of pain killers and other anesthetics that are given to a patient
      during surgery. Researchers want to study how this drug works in cancer patients and review
      the patient's chart for pain levels and medication use after surgery. Part of this research
      involves studying the immune system of surgery patients.

      If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you
      have surgery and the morning after surgery while you are still in the hospital. This blood
      will be used to learn more about how your immune system works.

      After your second blood draw, your participation in this study will be over.

      This is an investigational study.

      Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
observational model: Cohort
time perspective: Prospective
measure: Pre and Post Surgical Lymphocyte Counts
time frame: 2 days
description: Lymphocyte counts determined by flow-cytometry and their function by cytotoxicity assays performed in the laboratory using samples obtained before and the morning after surgery. Patients who experience a reduction of less than 50% of their preoperative natural killer cell (NKC) activity considered as a success.
arm group label: Blood Draw Pre and Post Surgery
description: Patients within the UT MD Anderson Cancer Center who are scheduled for breast cancer surgery.
intervention type: Drug
intervention name: Dexmedetomidine
description: After induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour.
arm group label: Blood Draw Pre and Post Surgery
15cc of blood drawn prior or at the moment of anesthesia induction and the morning after
      surgery.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juan P. Cata, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Dexmedetomidine