<?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>IRCT20200726048213N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-12</date_registration>
      <primary_sponsor>Islamic Azad University of Rasht branch</primary_sponsor>
      <public_title>Effect of Aerobic Training and Pomegranate Juice in Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Aerobic Training and Pomegranate Juice on micRNAs levels associated with Oxidant-Antioxidant Systems in Survivors of Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49929</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, the simultaneous effects of airobic training and Pomegranate juice consumtion has been investigated on progression of Breast cancer by monitoring some of the microRNAs and oxidant agents associated with cancer.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: aerobic exercise with Stationary Bike, 60 to 90 minutes, 3 sessions per week, for 8 weeks. Intervention 2: Intervention group: Natural pomegranate juice, 100 cc, fasting every morning, for 8 weeks. Intervention 3: Intervention group: aerobic exercise and pomegranate juice, 60 to 90 minutes of exercise, 3 sessions per week with pomegranate juice, 100 cc, fasting every morning,  for 8 weeks. Intervention 4: Control group: Without exercise training and consumption of pomegranate juice.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Babak Rouzbehan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Rasht branch, Taleshan Bridge, Lakan blvd, Raht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>351641335</zip>
        <telephone>+98 13 3342 3153</telephone>
        <email>rouzbehan@iaurasht.ac.ir</email>
        <affiliation>Islamic Azad University of Rasht branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Abed Natanzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 4486 5154</telephone>
        <email>h-abednatanzy@srbiru.ac.ir</email>
        <affiliation>Islamic Azad University of Tehran Science and Research Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All Women with Breast Cancer
The age range beween 30 and 45
Completion of Treatment courses like Chemotherapy and Radiation</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Physiological Menopause at the time of Cancer diagnosis
The History of Specialized Treatment like Chemotherapy and Radiation in the last Six Months
Performing Cancer-related Surgeries
Chronic systematic disease, such as Diabetes and Hypertension
Cardiovascular disease such as Heart Failure, Crononary Artery Disorders and severe Hypertension
Hormonal abnormalities and immunity disorders
Known Mental illness
Tobacco and Alcohol use
Problems, defects and disease of muscuskeletal system- preventative of Sport activity
The history of ongoing Sports exercises before the study begins
Cancer cells metastatis and involved of the other Body tissues and Organs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: aerobic exercise with Stationary Bike, 60 to 90 minutes, 3 sessions per week, for 8 weeks</i_keyword>
      <i_keyword>Intervention group: Natural pomegranate juice, 100 cc, fasting every morning, for 8 weeks</i_keyword>
      <i_keyword>Intervention group: aerobic exercise and pomegranate juice, 60 to 90 minutes of exercise, 3 sessions per week with pomegranate juice, 100 cc, fasting every morning,  for 8 weeks</i_keyword>
      <i_keyword>Control group: Without exercise training and consumption of pomegranate juice</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with decrease in the level of mir-21. Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>The percentage of people with decrease  in the level of mir-155. Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>The percentage of people with increase in the level of mir-34. Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum levels of oxidant factor; Malondialdehyde (MDA). Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</sec_outcome>
      <sec_outcome>Serum levels of antioxidant factor; Glutathione Peroxidase (GPX). Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</sec_outcome>
      <sec_outcome>Serum levels of antioxidant factor; Superoxide Dismutase (SOD). Timepoint: 48 hours before the onset and 48 hours after the end of study. Method of measurement: Blood Test.</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>Islamic Azad University of Rasht branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics committee of Qom University</contact_name>
        <contact_address>University of Qom, Alghadir Blvd., Qom, Iran Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
