<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/NCT04435028</url>
  </required_header>
  <id_info>
    <org_study_id>1890-1-2019</org_study_id>
    <nct_id>NCT04435028</nct_id>
  </id_info>
  <brief_title>Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy</brief_title>
  <official_title>Ketotifen: Novel Use as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy as Well as the Potential Beneficial Effects of Ketotifen in the Hypothetical Management of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Horus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Horus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study was to evaluate the expected cardioprotective effects of ketotifen&#xD;
      due to its activity as an iron-chelating agent previously uncovered by us in the in vitro&#xD;
      chemical test which included in the study, when used in patients receiving anthracyclines for&#xD;
      the treatment of breast cancer. The study was a randomized : , prospective controlled trial :&#xD;
      , and the patients were identified by coded numbers to maintain privacy. Eligible patients&#xD;
      (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy&#xD;
      (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients&#xD;
      received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent.&#xD;
      Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during&#xD;
      the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all&#xD;
      patients, and echocardiography two times for each patient at baseline and after 6 months&#xD;
      (EF%).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of our study was to evaluate the expected cardioprotective effects of ketotifen&#xD;
      due to its activity as an iron-chelating agent previously uncovered by us in the in vitro&#xD;
      chemical test which included in the study, when used in patients receiving anthracyclines for&#xD;
      the treatment of breast cancer. The study was a randomized : , prospective controlled trial :&#xD;
      , and the patients were identified by coded numbers to maintain privacy. Eligible patients&#xD;
      (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy&#xD;
      (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients&#xD;
      received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent.&#xD;
      Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during&#xD;
      the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all&#xD;
      patients, and echocardiography two times for each patient at baseline and after 6 months&#xD;
      (EF%).&#xD;
&#xD;
      The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity&#xD;
      induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline.&#xD;
&#xD;
      Because coronaviruses theoretically induce iron overload so, ketotifen has a potential&#xD;
      beneficial effect in the management of COVID-19 as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">August 13, 2019</completion_date>
  <primary_completion_date type="Actual">August 13, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines</measure>
    <time_frame>6 months</time_frame>
    <description>the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">111</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Iron Chelation</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ketotifen group</arm_group_label>
    <description>Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketotifen 1 MG</intervention_name>
    <description>Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>ketotifen group</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study participants were recruited from the Oncology Department, Menoufia University&#xD;
        Hospital, Egypt. The study was designed and conducted in compliance with the ethical&#xD;
        principles of Good Clinical Practice Guidelines and the Declaration of Helsinki&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cancer patients receiving anthracycline chemotherapy in their protocol alone (without&#xD;
             any cardioprotective agent),&#xD;
&#xD;
          -  aged 30-60, and&#xD;
&#xD;
          -  female subjects were included as they were female breast cancer patients, and,&#xD;
&#xD;
          -  patients who had an adequate baseline echocardiography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who had a history of heart failure,&#xD;
&#xD;
          -  arrhythmia,&#xD;
&#xD;
          -  cardiac catheterizations,&#xD;
&#xD;
          -  angina,&#xD;
&#xD;
          -  uncontrolled hypertension, and&#xD;
&#xD;
          -  uncontrolled diabetes,&#xD;
&#xD;
          -  patients with impaired liver function tests,&#xD;
&#xD;
          -  patients who previously received anthracycline-containing regimens, and&#xD;
&#xD;
          -  any cardiotoxic chemotherapy regimens, previous history of chest wall irradiation.&#xD;
&#xD;
          -  Brian metastasis.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>as the study was on breast cancer female patients</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Horus University</name>
      <address>
        <city>Damietta</city>
        <state>Damiete Governonate</state>
        <zip>12345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Horus University</investigator_affiliation>
    <investigator_full_name>hosny ahmed elewa</investigator_full_name>
    <investigator_title>head of pharmacy practice department</investigator_title>
  </responsible_party>
  <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>Ketotifen</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/NCT04435028
org study id: 1890-1-2019
nct id: NCT04435028
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen
      due to its activity as an iron-chelating agent previously uncovered by us in the in vitro
      chemical test which included in the study, when used in patients receiving anthracyclines for
      the treatment of breast cancer. The study was a randomized : , prospective controlled trial :
      , and the patients were identified by coded numbers to maintain privacy. Eligible patients
      (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy
      (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients
      received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent.
      Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during
      the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all
      patients, and echocardiography two times for each patient at baseline and after 6 months
      (EF%).
The objective of our study was to evaluate the expected cardioprotective effects of ketotifen
      due to its activity as an iron-chelating agent previously uncovered by us in the in vitro
      chemical test which included in the study, when used in patients receiving anthracyclines for
      the treatment of breast cancer. The study was a randomized : , prospective controlled trial :
      , and the patients were identified by coded numbers to maintain privacy. Eligible patients
      (111) fulfilled the criteria. Control Group: 55 patients received their standard therapy
      (anthracycline-containing chemotherapy without ketotifen). Ketotifen Group: 56 patients
      received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent.
      Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during
      the chemotherapeutic cycle for 6 cycles of treatment. Blood samples were obtained from all
      patients, and echocardiography two times for each patient at baseline and after 6 months
      (EF%).

      The aim is to prove and evaluate the prophylasis effect of ketotifin from cardiotoxicity
      induced by anthracyclines therapy without decreasing the anti-tumor action of anthracycline.

      Because coronaviruses theoretically induce iron overload so, ketotifen has a potential
      beneficial effect in the management of COVID-19 as well.
observational model: Other
time perspective: Prospective
measure: prophylaxis effect of Ketotifen on patient's hearts during the treatment of anthracyclines
time frame: 6 months
description: the serum levels of LDH, CK-MB, troponin I, TIBC, ferritin, anti-cardiolipin IgG, and, iron were done
arm group label: control group
description: 55 patients received their standard therapy (anthracycline-containing chemotherapy without ketotifen)
arm group label: ketotifen group
description: Ketotifen Group: 56 patients received anthracycline-containing chemotherapy plus ketotifen as a cardioprotective agent. Ketotifen will be given orally as one tablet (1 mg/tablet) 3 times daily, before and during the chemotherapeutic cycle for 6 cycles of treatment
intervention type: Drug
intervention name: Ketotifen 1 MG
description: Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
arm group label: control group
arm group label: ketotifen group
other name: placebo
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: as the study was on breast cancer female patients
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Horus University
investigator full name: hosny ahmed elewa
investigator title: head of pharmacy practice department
mesh term: Breast Neoplasms
mesh term: Ketotifen