<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/NCT01724450</url>
  </required_header>
  <id_info>
    <org_study_id>Ceccy Trial</org_study_id>
    <nct_id>NCT01724450</nct_id>
  </id_info>
  <brief_title>Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity</brief_title>
  <acronym>Ceccy</acronym>
  <official_title>Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital A.C. Camargo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after&#xD;
      chemotherapy in breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated&#xD;
      cardiomyopathies.&#xD;
&#xD;
      Initial studies showed beneficial effect of the use of carvedilol for the prevention of&#xD;
      chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the&#xD;
      effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will&#xD;
      be selected 200 patients referred for chemotherapy that includes anthracyclines for breast&#xD;
      cancer.These patients will be randomized to carvedilol or placebo and will have periodic&#xD;
      assessment of cardiac function with echocardiography and biomarkers until complete&#xD;
      chemotherapy and 24 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.</measure>
    <time_frame>96 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction.</measure>
    <time_frame>96 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Heart Failure</condition>
  <condition>Cardiotoxicity</condition>
  <arm_group>
    <arm_group_label>Carvedilol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carvedilol</intervention_name>
    <description>50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day</description>
    <arm_group_label>Carvedilol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo similar to the carvedilol up titration but wit no active drug.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients diagnosed with breast cancer, with an indication of chemotherapy that includes&#xD;
        anthracycline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous&#xD;
        symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease;&#xD;
        Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the&#xD;
        use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor&#xD;
        blockers or β-blockers.&#xD;
&#xD;
        Patients with HER 2 expression&#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>Edimar Alcides Bocchi, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Institute of University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Institute University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>June 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Edimar Alcides Bocchi</investigator_full_name>
    <investigator_title>phd</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Cardiotoxicity</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiotoxicity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carvedilol</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/NCT01724450
org study id: Ceccy Trial
nct id: NCT01724450
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after
      chemotherapy in breast cancer.
Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated
      cardiomyopathies.

      Initial studies showed beneficial effect of the use of carvedilol for the prevention of
      chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the
      effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will
      be selected 200 patients referred for chemotherapy that includes anthracyclines for breast
      cancer.These patients will be randomized to carvedilol or placebo and will have periodic
      assessment of cardiac function with echocardiography and biomarkers until complete
      chemotherapy and 24 months later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.
time frame: 96 weeks
measure: Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction.
time frame: 96 weeks
arm group label: Carvedilol
arm group type: Active Comparator
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Carvedilol
description: 50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
arm group label: Carvedilol
intervention type: Drug
intervention name: Placebo
description: Placebo similar to the carvedilol up titration but wit no active drug.
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Edimar Alcides Bocchi, PHD
role: Principal Investigator
affiliation: Heart Institute of University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Edimar Alcides Bocchi
investigator title: phd
mesh term: Heart Failure
mesh term: Cardiotoxicity
mesh term: Carvedilol