<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/NCT04434404</url>
  </required_header>
  <id_info>
    <org_study_id>32551/09/2018</org_study_id>
    <nct_id>NCT04434404</nct_id>
  </id_info>
  <brief_title>Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy</brief_title>
  <official_title>Cardioprotection of Silymarin for Patients Received Anthracycline Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Horus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Horus University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</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 study aim to protect patients received anthracyclines containing chemotherapy from&#xD;
      cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for&#xD;
      protection the heart from anthracyclines toxicities, and in addition its a comparitive study&#xD;
      between L-carnitine and Silymarin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in&#xD;
      treatment of various types of cancer. This study aimed to investigate benefits from adding&#xD;
      L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with&#xD;
      cancer.&#xD;
&#xD;
      Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University,&#xD;
      Egypt, then prospectively randomized to receive their anthracycline containing therapeutic&#xD;
      regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or&#xD;
      anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at&#xD;
      begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin&#xD;
      and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA&#xD;
      and paired t test. P &lt;0.05 was statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">August 13, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy</measure>
    <time_frame>from the baseline untill 3 months</time_frame>
    <description>addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy</measure>
    <time_frame>from the baseline untill 3 months</time_frame>
    <description>addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L-carnitine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silymarin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-Carnitine 500Mg Oral Tablet</intervention_name>
    <description>eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study&#xD;
without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months.</description>
    <arm_group_label>L-carnitine group</arm_group_label>
    <arm_group_label>Silymarin group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>Silymarin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cancer patients receiving anthracycline chemotherapy in their protocol alone (without&#xD;
             any cardioprotective agent),&#xD;
&#xD;
          -  aged 20-60 and&#xD;
&#xD;
          -  female patients were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of heart failure, arrhythmia, history of cardiac&#xD;
             catheterizations or, history of angina, uncontrolled hypertension and uncontrolled&#xD;
             diabetes,&#xD;
&#xD;
          -  patients with impaired liver function tests,&#xD;
&#xD;
          -  previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens,&#xD;
&#xD;
          -  previous history of chest wall irradiation.&#xD;
&#xD;
          -  Brain metastasis,&#xD;
&#xD;
          -  pregnant patients and&#xD;
&#xD;
          -  patients who refused informed consent,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>as all our participants were breast cancer patients</gender_description>
    <minimum_age>20 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>Tanta City</state>
        <zip>34518</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 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 16, 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>
  <keyword>anthracycline-containg chemotherapy</keyword>
  <keyword>cardiotoxicity</keyword>
  <keyword>breast cancer patients</keyword>
  <keyword>slymarin</keyword>
  <keyword>l-carnitine</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>Silymarin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04434404
org study id: 32551/09/2018
nct id: NCT04434404
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
the study aim to protect patients received anthracyclines containing chemotherapy from
      cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for
      protection the heart from anthracyclines toxicities, and in addition its a comparitive study
      between L-carnitine and Silymarin.
Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in
      treatment of various types of cancer. This study aimed to investigate benefits from adding
      L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with
      cancer.

      Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University,
      Egypt, then prospectively randomized to receive their anthracycline containing therapeutic
      regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or
      anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at
      begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin
      and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA
      and paired t test. P <0.05 was statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was a parallel randomized (simple randomization; odd number took silymarin and even number took l carnitine) controlled prospective open label one.
primary purpose: Prevention
masking: Single (Participant)
measure: The use of l-carnitine may be of use in extending the continuous use of anthracycline-containing chemotherapy
time frame: from the baseline untill 3 months
description: addition of l-carnitine to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy
measure: The use of silymarin may be of use in extending the continuous use of anthracycline-containing chemotherapy
time frame: from the baseline untill 3 months
description: addition of silymarin to the traditional therapy of breast cancer patients protocol containing anthracycline chemotherapy
arm group label: control group
arm group type: Placebo Comparator
description: 33, patients in the control group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 without cardioprotective agents
arm group label: L-carnitine group
arm group type: Active Comparator
description: 25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine
arm group label: Silymarin group
arm group type: Active Comparator
description: 25 patients received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin140 mg
intervention type: Drug
intervention name: L-Carnitine 500Mg Oral Tablet
description: eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study
without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months.
arm group label: L-carnitine group
arm group label: Silymarin group
arm group label: control group
other name: Silymarin
criteria: 
gender: Female
gender based: Yes
gender description: as all our participants were breast cancer patients
minimum age: 20 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: Silymarin
sharing ipd: No