<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190303042892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-11</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of co-administration of quercetin supplemented cardiac cardiovascular system with cardiotoxicity of doxorubicin in patients with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Cardioprotective effect of quercetin supplement in against of cardiac induced toxicity of doxorubicin in breast cancer patients: a randomized, double-blined, placebo-controlled trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Limited Randomization is done in which both groups have the same sample size and the random allocation rule is also used to balance the number of people assigned to each group. For this purpose, SAS software and websites www.graghpad.com/quickcalcs/index.cf are used. Moreover, the SNOSE method is used to hide the allocation, the use of non-transparent sealed packets with random sequences, Blinding description: In this randomized clinical trial , placebo-controlled (Phase II), which is done in double blind (all patients and researchers are blinded to studying),of 100 women with breast cancer (C50-C50 disease code) ; Malignant neoplasm of breast). With the initial diagnosis and referral to the Behesht Clinic of Rasht in year 2018, which will be treated with anthracycline (doxorubicin) will be used.</study_design>
      <phase>2</phase>
      <hc_freetext>Patients with Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group receiving oral quercetin supplementation. Oral supplementation Quercetin (pure America manufacturer) continues 2 weeks before starting a chemotherapy dose of 250 mg (once a day) from the beginning and end of the chemotherapy (3 months) period. Intervention 2: Control group: the patients in the control group who received two They will receive a placebo week before the end of the course. Oral supplements of quercetine and placebo are similar in appearance, color and odor.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I do not currently have the authority to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Hadad Zahmatkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3361 8177</telephone>
        <email>haddad@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Hadad Zahmatkesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55588</zip>
        <telephone>+98 13 3361 8177</telephone>
        <email>haddad@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eligible patients include women aged 21-69 years with sinus rhythm and normal ventricular drainage fraction, normal liver and kidney function, and normal hematology.Previously don`t have any document for chemotherapy or radiotherapy for other types of malignancies. They don`t have CHF. Have not experienced myocardial infarction. Do not suffer from obstruction or heart valves stenosis. They don`t have specific disease or specific drug therapy that affects cardiac function. EF do not have less than 55%.They don`t have cardiovascular disease risk factors , such as hypertension, high fat,  and do not include smokers. Women in this clinical trial study are not pregnant and don`t have  systolic pressure of less than 90 mmHg.</inclusion_criteria>
      <agemin>1360 years</agemin>
      <agemax>1360 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to appear in the plan, to make any changes to the treatment or use of the drug. At any time from the implementation of the plan, in the event of any unwanted side effects, the oral supplement will be discontinued and the patient will be excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Breast, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group receiving oral quercetin supplementation. Oral supplementation Quercetin (pure America manufacturer) continues 2 weeks before starting a chemotherapy dose of 250 mg (once a day) from the beginning and end of the chemotherapy (3 months) period.</i_keyword>
      <i_keyword>Control group: the patients in the control group who received two They will receive a placebo week before the end of the course. Oral supplements of quercetine and placebo are similar in appearance, color and odor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The cardiac toxicity of doxorubicin is a primary outcome. Timepoint: The amount of troponin is measured one month after the start of chemotherapy and the end of the course. Method of measurement: Troponin test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quercetin cardiovascular effect is a secondary consequence. Timepoint: Echocardiography will be done at the end of the chemotherapy (first 3 months), 6 months later and one year later. Method of measurement: Echocardiography.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-23</approval_date>
        <contact_name>Guilan University of Medical Sciences</contact_name>
        <contact_address>Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
