<?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>IRCT2016022726779N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-21</date_registration>
      <primary_sponsor>Deputy of research and technology of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of physical Therapy treatments in Patients with Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of Complex Decongestive physical Therapy and Combination of Intermittent Pneumatic Compression Pump and Complex Decongestive physical Therapy on Lymphedema Volume and Quality of Life in Patients with Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22095</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>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Treatments for intervention group (CDP+IPC) includes manual lymphatic drainage for 30 minutes in each session, multi-layer bandaging, exercise , skin and nail care and applicatin of intermittent penumatic compression device.Intermittent pressure is applied with a pressure about 40 mmHg for 30 minutes by using of IPC Lymphatron model 850 with six chambers.Special bandages which are known as short -stretch or low-stretch bandages are used in lymphedema bandage.This type of bandage is appropriate to reduce the size of swollen extremities physiologically, the probability of damage due to excessive pressure is very low. This bandage is used for 24 hours during the treatment phase. The bandage is done in figure of eight from distal to proximal in the affected limb. Intervention 2: Treatment for control group (CDP) includes manual lymphatic drainage  for 30 minutes in each session, multi-layer bandaging, exercise and skin and nail care.Special bandages which are known as short -stretch or low-stretch bandages are used in lymphedema bandage.This type of bandage is appropriate to reduce  the size of swollen extremities physiologically, the probability of damage due to excessive pressure is very low. This bandage is used for 24 hours  during the treatment phase. The bandage is done in figure of eight from distal to proximal in the affected limb.</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>Miss Sepide Nafissi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Avenue, Pichshemiran, Faculty of Rehabilitation-Tehran Universaity of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 2286 3221</telephone>
        <email>sepide_nafissi@gmail.com</email>
        <affiliation>Tehran Universaity of Medical Sciences, Faculty of Rehabilitation</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Avenue, Pichshemiran, Faculty of Rehabilitation-Tehran Universaity of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>hbagheri@tums.ac.ir</email>
        <affiliation>Tehran Universaity of Medical Sciences, Faculty of Rehabilitation</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: unilateral upper extremity lymphedema ; The severity of lymphedema with grade 2; No  previous treatment for lymphedema&#13;
&#13;
&#13;
Exclusion criteria: The return of cancer; infection in the arm; intolerance bandage.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatments for intervention group (CDP+IPC) includes manual lymphatic drainage for 30 minutes in each session, multi-layer bandaging, exercise , skin and nail care and applicatin of intermittent penumatic compression device.Intermittent pressure is applied with a pressure about 40 mmHg for 30 minutes by using of IPC Lymphatron model 850 with six chambers.Special bandages which are known as short -stretch or low-stretch bandages are used in lymphedema bandage.This type of bandage is appropriate to reduce the size of swollen extremities physiologically, the probability of damage due to excessive pressure is very low. This bandage is used for 24 hours during the treatment phase. The bandage is done in figure of eight from distal to proximal in the affected limb.</i_keyword>
      <i_keyword>Treatment for control group (CDP) includes manual lymphatic drainage  for 30 minutes in each session, multi-layer bandaging, exercise and skin and nail care.Special bandages which are known as short -stretch or low-stretch bandages are used in lymphedema bandage.This type of bandage is appropriate to reduce  the size of swollen extremities physiologically, the probability of damage due to excessive pressure is very low. This bandage is used for 24 hours  during the treatment phase. The bandage is done in figure of eight from distal to proximal in the affected limb.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Limb lymph oedema volume. Timepoint: Before intervention and after ten sessions of treatment. Method of measurement: Using a volumeter, limb volume is measured by water displacement(mililiters).</prim_outcome>
      <prim_outcome>Limb circumference. Timepoint: Before intervention and after ten sessions of treatment. Method of measurement: by a tape (cm).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before intervention and after ten sessions of treatment. Method of measurement: using of two questionnaires( QLQ-C30, QLQ-BR23).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion of shoulder joints. Timepoint: Before intervention and after ten sessions of treatment. Method of measurement: using a goniometer (degrees).</sec_outcome>
      <sec_outcome>Limb heaviness. Timepoint: Before intervention and after ten sessions of treatment. Method of measurement: Visual Analog Scale (cm or mm).</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>Deputy of research and technology of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-02-07</approval_date>
        <contact_name>Deputy of Research and technology of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran- Bolvar Keshavarz Avenue- Entrance of Ghods Ave- Central organisation of University-Sixth Floor Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
