<?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>IRCT20090613002027N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-01</date_registration>
      <primary_sponsor>Mazandaran University of Medical Scienses</primary_sponsor>
      <public_title>Efficacy and safety of bupropion in cancer-related fatigue</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and safety of bupropion in cancer-related fatigue, a randomized double blind placebo controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will enter the trial randomly based on the random number table, Blinding description: participants, principle investigator, healthcare providers,  data collectors and outcome assessors.</study_design>
      <phase>2</phase>
      <hc_freetext>Cancer related fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: administration of bupropion (made by Abidi pharmaceuticals) 75 mg once a day (for three days) then 75 mg twice a day till the end of study (six weeks). Intervention 2: Control group: administration of placebo once a day for the first three days then twice a day till the end of study.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Salehifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>861-48175</zip>
        <telephone>+98 11 3354 3241</telephone>
        <email>salehifare@yahoo.com</email>
        <affiliation>Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Salehifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>861-48175</zip>
        <telephone>+98 11 3354 3241</telephone>
        <email>salehifare@yahoo.com</email>
        <affiliation>Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients suffering from cancer-related fatigue
Score of at least 4 based on BFI (Brief Fatigue Inventory) scale  (0-10)
Fatigue with unknown reason for at least one week and more</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Age under 18
History of use of the CNS stimulants and antidepressants
History of seizure
History of use of erythropoietin in the last six weeks.
History of suicide
Use of MAOIs (Mono Amino Oxidase Inhibitors) in the last two weeks
Liver and renal failure
Pregnancy and lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y43.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drugs, medicaments and biological substances causing adverse effects in therapeutic use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: administration of bupropion (made by Abidi pharmaceuticals) 75 mg once a day (for three days) then 75 mg twice a day till the end of study (six weeks)</i_keyword>
      <i_keyword>Control group: administration of placebo once a day for the first three days then twice a day till the end of study</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score based on BFI scale. Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: BFI questionnaire.</prim_outcome>
      <prim_outcome>Fatigue score based on Functional Assessment of Chronic Illness Therapy (FACIT). Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: FACIT questionnaire.</prim_outcome>
      <prim_outcome>Degree of depression an anxiety based on Hospital Anxiety and Depression scale (HADS). Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: HADS questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Performance status based on Eastern Cooperative Oncology Group (ECOG). Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: ECOG questionnaire.</sec_outcome>
      <sec_outcome>Performance status based on Karnofsky Performance Status Scale. Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: Karnofsky questionnaire.</sec_outcome>
      <sec_outcome>Patient's quality of life based on European Organisation for Research and Treatment of Cancer QLQ-C30. Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: EORTC QLQ-C30 questionnaire.</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>Mazandaran University of Medical Scienses</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-20</approval_date>
        <contact_name>Mazandaran University of Medical Scienses Ethical Committee</contact_name>
        <contact_address>Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran Sari Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
