<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672125</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-EG-449-CTIL</org_study_id>
    <nct_id>NCT01672125</nct_id>
  </id_info>
  <brief_title>Effect of Upper Limb Posture on Limb Volume as Expressed in Circumference Measurement in Healthy Women and in Women With Breast Cancer Related Lymphedema</brief_title>
  <official_title>Effect of Upper Limb Posture on Limb Volume as Expressed in Circumference Measurement in Healthy Women and in Women With Breast Cancer Related Lymphedema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb&#xD;
      enables monitoring changes in the lymphedema and the effect of treatment. Circumference&#xD;
      measurement using a measuring tape is an inexpensive simple method and therefore useful and&#xD;
      widespread in clinical practice. Circumference measurement performance varies amongst&#xD;
      therapists and lacks uniformity in the literature. To date, the effect of different limb&#xD;
      positions on measurement results has not been examined.&#xD;
&#xD;
      Purpose: The purpose of this study is to describe 1) the effect of position on upper limb&#xD;
      volume measurement by using circumference measurement and 2) to examine whether the&#xD;
      difference between positions are similar in the upper limbs of the same woman, and 3) between&#xD;
      groups of women who are in the intensive phase, in the maintenance phase of lymphedema&#xD;
      treatment and women without lymphedema&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Analytical cross section study Population: Inclusion criteria: 15 women who&#xD;
      have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in&#xD;
      the intensive phase of lymphedema treatment; 15 women who have completed breast cancer&#xD;
      treatment and are in the maintenance phase of lymph edema treatment and 15 healthy women&#xD;
      adjusted in age and BMI. Exclusion criteria: active cancer, cardiovascular disorder, wounds&#xD;
      or inflammation in the measured upper limb, and illness with fever.&#xD;
&#xD;
      Research tools: Questionnaire to gather personal details, information about the cancer and&#xD;
      the lymphedema. Plastic, retractable measuring tape with an accuracy of 1 mm. Fixed points on&#xD;
      the limb are measured according to anatomical landmarks and afterwards the limb volume is&#xD;
      calculated using the formula for a truncated cone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Circumferential upper limb measurement</measure>
    <time_frame>3 hours for each subject</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>women who have completed treatments</arm_group_label>
    <description>women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women who have completed treatment in maintenance phase</arm_group_label>
    <description>women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy women</arm_group_label>
    <description>healthy women adjusted in age and BMI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>circumferential measurements in different upper limb positions.</intervention_name>
    <description>circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position</description>
    <arm_group_label>healthy women</arm_group_label>
    <arm_group_label>women who have completed treatment in maintenance phase</arm_group_label>
    <arm_group_label>women who have completed treatments</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women who have completed breast cancer treatments, with a diagnosis of unilateral arm&#xD;
        lymphedema, in the intensive phase and in the maintenance phase of lymphedema treatment, 15&#xD;
        healthy women adjusted in age and BMI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  15 women who have completed breast cancer treatments, with a diagnosis of unilateral&#xD;
             arm lymphedema, in the intensive phase of lymphedema treatment;&#xD;
&#xD;
          -  15 women who have completed breast cancer treatment and are in the maintenance phase&#xD;
             of lymph edema treatment and&#xD;
&#xD;
          -  15 healthy women adjusted in age and BMI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active cancer,&#xD;
&#xD;
          -  cardiovascular disorder,&#xD;
&#xD;
          -  wounds or inflammation in the measured upper limb, and&#xD;
&#xD;
          -  illness with fever.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ruthi Peleg, BPT</last_name>
    <phone>+97236973104</phone>
    <email>ruthiwolff@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 23, 2012</last_update_submitted>
  <last_update_submitted_qc>August 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672125
org study id: TASMC-12-EG-449-CTIL
nct id: NCT01672125
lead sponsor: 
has dmc: No
Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb
      enables monitoring changes in the lymphedema and the effect of treatment. Circumference
      measurement using a measuring tape is an inexpensive simple method and therefore useful and
      widespread in clinical practice. Circumference measurement performance varies amongst
      therapists and lacks uniformity in the literature. To date, the effect of different limb
      positions on measurement results has not been examined.

      Purpose: The purpose of this study is to describe 1) the effect of position on upper limb
      volume measurement by using circumference measurement and 2) to examine whether the
      difference between positions are similar in the upper limbs of the same woman, and 3) between
      groups of women who are in the intensive phase, in the maintenance phase of lymphedema
      treatment and women without lymphedema
Study design: Analytical cross section study Population: Inclusion criteria: 15 women who
      have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in
      the intensive phase of lymphedema treatment; 15 women who have completed breast cancer
      treatment and are in the maintenance phase of lymph edema treatment and 15 healthy women
      adjusted in age and BMI. Exclusion criteria: active cancer, cardiovascular disorder, wounds
      or inflammation in the measured upper limb, and illness with fever.

      Research tools: Questionnaire to gather personal details, information about the cancer and
      the lymphedema. Plastic, retractable measuring tape with an accuracy of 1 mm. Fixed points on
      the limb are measured according to anatomical landmarks and afterwards the limb volume is
      calculated using the formula for a truncated cone.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Circumferential upper limb measurement
time frame: 3 hours for each subject
arm group label: women who have completed treatments
description: women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment
arm group label: women who have completed treatment in maintenance phase
description: women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment
arm group label: healthy women
description: healthy women adjusted in age and BMI
intervention type: Other
intervention name: circumferential measurements in different upper limb positions.
description: circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position
arm group label: healthy women
arm group label: women who have completed treatment in maintenance phase
arm group label: women who have completed treatments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ruthi Peleg, BPT
phone: +97236973104
email: ruthiwolff@gmail.com
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema