<?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>IRCT201011095144N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-01-28</date_registration>
      <primary_sponsor>Nutririon research center</primary_sponsor>
      <public_title>Effect of ω-3 fatty acids on gastric cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Study on the effect of ω-3 fatty acids supplementation on nutritional status, some inflammatory factors and  matrix metalloproteinases in gastric cancer patients undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gastric cancer patients undergoing chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: Interventions 1: ω-3 fatty acids, 3 g daily for 45 days. Intervention 2: interventions2: rice powder, three capsules daily for 45 days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basic Science group, Faculty of Medicine, Ardebil University of Medical Sciences</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 45 1551 0052</telephone>
        <email>a.nemati@arums.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  Patients with gastric cancer in phase 3 (cardia and non cardia) during chemotherapy over 30 years old.&#13;
Exclusion criteria: other diseases induced cachexia such as heart disease, lung, AIDS, renal disease, incidence of acute leukemia, diabetes and multiple myeloma, individauls undergoing surgery and who do not take the given drugs properly during the study period.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of stomach</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions 1: ω-3 fatty acids, 3 g daily for 45 days</i_keyword>
      <i_keyword>interventions2: rice powder, three capsules daily for 45 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight. Timepoint: days of 0, 30 and 45. Method of measurement: digital scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: days of 0, 30 and 45. Method of measurement: measured by ratio of weight (kilograms) to squared height (m).</sec_outcome>
      <sec_outcome>Daily calorie intake. Timepoint: days of 0, 30 and 45. Method of measurement: 24 hour recall questionnaire.</sec_outcome>
      <sec_outcome>Daily nutreints  intake. Timepoint: days of 0, 30 and 45. Method of measurement: 24 hour recall questionnaire.</sec_outcome>
      <sec_outcome>Nausea. Timepoint: days of 0, 30 and 45. Method of measurement: quaistionnaire.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: days of 0, 30 and 45. Method of measurement: quaistionnaire.</sec_outcome>
      <sec_outcome>Appetite. Timepoint: days of 0, 30 and 45. Method of measurement: quaistionnaire.</sec_outcome>
      <sec_outcome>Dairreha. Timepoint: days of 0, 30 and 45. Method of measurement: quaistionnare.</sec_outcome>
      <sec_outcome>Abdominal cramp. Timepoint: days of 0, 30 and 45. Method of measurement: quaistionnaire.</sec_outcome>
      <sec_outcome>Total antioxidant. Timepoint: days of 0, 30 and 45. Method of measurement: spectrophotometry.</sec_outcome>
      <sec_outcome>MDA. Timepoint: days of 0, 30 and 45. Method of measurement: spectrophotometry.</sec_outcome>
      <sec_outcome>Interleukin1. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Interleukin 6. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Interleukin 2. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>TNF-ɑ. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Mmp9. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Mmp2. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Cholestrol. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>Triglyceride. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>TIBC. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>Blood albumin. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>LDL- C. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>HDL-C. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>Blood iron. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>CRP. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</sec_outcome>
      <sec_outcome>Proxonaz 1. Timepoint: days of 0, 30 and 45. Method of measurement: spectophotometry.</sec_outcome>
      <sec_outcome>IgA. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IgG. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>IgM. Timepoint: days of 0, 30 and 45. Method of measurement: ELISA.</sec_outcome>
      <sec_outcome>Transferrin. Timepoint: days of 0, 30 and 45. Method of measurement: autoanalyzer.</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>Nutririon research center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-12-01</approval_date>
        <contact_name>Vice Chancellor of Research in Tabrizl University of medical sciences</contact_name>
        <contact_address>Vice Chancellor of Research, Tabriz University of medical sciences, Daneshgah St. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
