<?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>IRCT138902212621N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-04-30</date_registration>
      <primary_sponsor>Shiraz university of medical sciences</primary_sponsor>
      <public_title>The effect of combined decongestive therapy and pneumatic compression pump on lymphedema indicators and body image in patients with  lymphedema secondary to breast cancer treatment</public_title>
      <acronym>CDT+ PCP</acronym>
      <scientific_title>The effect of combined decongestive therapy and pneumatic compression pump on lymphedema indicators and body image in patients with  lymphedema secondary to breast cancer treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2397</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>postmastectomy lymphedema.</hc_freetext>
      <i_freetext>Intervention 1: Patients in in the control group received no treatment for lymphedema. Intervention 2: CDT in the intervention group was done in two phases. In the first phase CDT was performed with a compression pump for 4 weeks, 3 days per week. In the second phase, CDT was performed daily without a pump for 4 consecutive weeks by patients at home.</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>Badri Jaafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>unit 13, block 12, phase 2, Isargaran appartments, Emam Kkomeini St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7178899449</zip>
        <telephone>+98 71 1835 2694</telephone>
        <email>jafary_227@yahoo.com</email>
        <affiliation>Shiraz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Marzieh Moattari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College of Nursing &amp; Midwifery, Shiraz University of Medical Sciences, Zand St.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4250</telephone>
        <email>moattari@yahoo.com , moattarm@sums.ac.ir</email>
        <affiliation>Shiraz university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1.histoty of breast cancer, 2.history of surgery and chemotherapy and as needed hormone therapy and radiotherapy, 3. affected by lymphedema (with degree of mild to severe) based on specialist diagnosis, 4. at least 1 year ago was undergone axillary node dissection, 5. do not have knowledge about combined decongestive therapy, 6. phone accessibility, 7. 35-70 years old. Exclusion criteria: 1. psychotic disorder, 2. existence sever pain at axillary area, 3. history of hysterectomy duo to uterus  cancer, 4. severe cardiac disease, 5. heart failure, 6. renal failure, 7. severe hypertension, 8.  existing other malignancies, 9. recurrent infection in arm, 10. musclo skeletal disease</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postmastectomy lymphoedema syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in in the control group received no treatment for lymphedema.</i_keyword>
      <i_keyword>CDT in the intervention group was done in two phases. In the first phase CDT was performed with a compression pump for 4 weeks, 3 days per week. In the second phase, CDT was performed daily without a pump for 4 consecutive weeks by patients at home.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Differences in volume of both upper limbs. Timepoint: before the intervention, 4 and 8 weeks after that. Method of measurement: volumeter.</prim_outcome>
      <prim_outcome>Difference in circumference between the two  upper limbs. Timepoint: before the intervention, 4 and 8 weeks after that. Method of measurement: meter.</prim_outcome>
      <prim_outcome>Shoulder joint range of motion. Timepoint: before the intervention, 4 and 8 weeks after that. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Body image and relationships. Timepoint: before the intervention, 4 and 8 weeks after that. Method of measurement: body image and relationships scale (questionare).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adduction motion of shoulder joint. Timepoint: before the intervention, 4 and 8 weeks after that. Method of measurement: goniometer.</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>Shiraz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>1990-01-01</approval_date>
        <contact_name>Vice chancellor for research, Shiraz university of medical sciences</contact_name>
        <contact_address>Zand St. Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
