<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/NCT03765996</url>
  </required_header>
  <id_info>
    <org_study_id>2301-GOA</org_study_id>
    <nct_id>NCT03765996</nct_id>
  </id_info>
  <brief_title>Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema</brief_title>
  <official_title>Effectiveness of Kinesio® Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the most common conservative treatments of lymphoedema is Complex Decongestive&#xD;
      Physiotherapy (CDP). The bandage is one of the most important components of the treatment&#xD;
      process. The multilayer short-stretch bandage is used to maintain volume reduction and&#xD;
      prevent lymph backflow caused by compression. However, some patients refuse or postpone&#xD;
      treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a&#xD;
      new technique for managing lymphoedema in the field of physical and alternative therapy, and&#xD;
      it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which&#xD;
      showed that KT was an effective for patients with BCRL, it was applied on both the affected&#xD;
      arm and anastomosis. One of these studies also reported that a significant reduction in limb&#xD;
      volume in patients who were applied of the tape only to the affected arm. This significant&#xD;
      effect could also be seen by applying KT only to the anastomosis. In literature, however,&#xD;
      there is no evidence to support this theory. So the aim of this study is to determine the&#xD;
      effectiveness of KT which was applied to anastomotic regions along with CDP in the management&#xD;
      of BCRL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">January 1, 2015</completion_date>
  <primary_completion_date type="Actual">January 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)</measure>
    <time_frame>At baseline and at 4 weeks</time_frame>
    <description>Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Breast Cancer Lymphedema</condition>
  <condition>Compression Bandages</condition>
  <condition>Manual Lymphatic Drainage</condition>
  <arm_group>
    <arm_group_label>Decongestive Physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received Complex Decongestive Physiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decongestive Physiotherapy plus taping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decongestive Physiotherapy</intervention_name>
    <description>This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.</description>
    <arm_group_label>Decongestive Physiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decongestive Physiotherapy plus taping</intervention_name>
    <description>This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.</description>
    <arm_group_label>Decongestive Physiotherapy plus taping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had unilateral BCRL and women aged over 18 who were 'significant',&#xD;
             'marked', or 'severe' lymphoedema.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with paralysis on part of the affected arm,&#xD;
&#xD;
          -  Patients who had undergone CDP more than once within six months,&#xD;
&#xD;
          -  Patients who had an active infection,&#xD;
&#xD;
          -  Patients who had a skin disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gülbin Ergin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European University of Lefke</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Didem Karadibak, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tuğba Yavuzşen, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. İsmail Atabek Physical Therapy and Rehabilitation Center</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>April 3, 2020</results_first_submitted>
  <results_first_submitted_qc>April 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2020</results_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Ertan Sahinoglu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients enrolled in the study between 2012 and 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Decongestive Physiotherapy</title>
          <description>This group received Complex Decongestive Physiotherapy.&#xD;
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.</description>
        </group>
        <group group_id="P2">
          <title>Decongestive Physiotherapy Plus Taping</title>
          <description>This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.&#xD;
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Decongestive Physiotherapy</title>
          <description>This group received Complex Decongestive Physiotherapy.&#xD;
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.</description>
        </group>
        <group group_id="B2">
          <title>Decongestive Physiotherapy Plus Taping</title>
          <description>This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.&#xD;
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.42" spread="7.69"/>
                    <measurement group_id="B2" value="58.44" spread="10.12"/>
                    <measurement group_id="B3" value="56.25" spread="9.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Four patients in control group excluded from the study due to not completed the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="14"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)</title>
        <description>Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).</description>
        <time_frame>At baseline and at 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Decongestive Physiotherapy</title>
            <description>This group received Complex Decongestive Physiotherapy.&#xD;
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.</description>
          </group>
          <group group_id="O2">
            <title>Decongestive Physiotherapy Plus Taping</title>
            <description>This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.&#xD;
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)</title>
          <description>Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).</description>
          <units>milliliter</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160.01" lower_limit="81.50" upper_limit="650.56"/>
                    <measurement group_id="O2" value="148.28" lower_limit="52.29" upper_limit="552.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 4 weeks</time_frame>
      <desc>Skin deterioration was expected due to bandage or taping, however, any skin allergy or wounds have not occurred in all patients.</desc>
      <group_list>
        <group group_id="E1">
          <title>Decongestive Physiotherapy</title>
          <description>This group received Complex Decongestive Physiotherapy.&#xD;
Decongestive Physiotherapy: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.</description>
        </group>
        <group group_id="E2">
          <title>Decongestive Physiotherapy Plus Taping</title>
          <description>This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.&#xD;
Decongestive Physiotherapy plus taping: This group received CDP as same protocol of active comparator. In addition, taping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ertan Şahinoğlu</name_or_title>
      <organization>Dr. İsmail Atabek Physiotherapy and Rehabilitation Center</organization>
      <phone>+90 532 647 86 53</phone>
      <email>ertan.sahinoglu@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03765996
org study id: 2301-GOA
nct id: NCT03765996
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
One of the most common conservative treatments of lymphoedema is Complex Decongestive
      Physiotherapy (CDP). The bandage is one of the most important components of the treatment
      process. The multilayer short-stretch bandage is used to maintain volume reduction and
      prevent lymph backflow caused by compression. However, some patients refuse or postpone
      treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a
      new technique for managing lymphoedema in the field of physical and alternative therapy, and
      it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which
      showed that KT was an effective for patients with BCRL, it was applied on both the affected
      arm and anastomosis. One of these studies also reported that a significant reduction in limb
      volume in patients who were applied of the tape only to the affected arm. This significant
      effect could also be seen by applying KT only to the anastomosis. In literature, however,
      there is no evidence to support this theory. So the aim of this study is to determine the
      effectiveness of KT which was applied to anastomotic regions along with CDP in the management
      of BCRL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)
time frame: At baseline and at 4 weeks
description: Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters. Limb measuring was carried out at the beginning of and after treatment (twenty sessions).
arm group label: Decongestive Physiotherapy
arm group type: Active Comparator
description: This group received Complex Decongestive Physiotherapy.
arm group label: Decongestive Physiotherapy plus taping
arm group type: Experimental
description: This group received Complex Decongestive Physiotherapy, and also applying taping to anastomosis regions.
intervention type: Other
intervention name: Decongestive Physiotherapy
description: This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
arm group label: Decongestive Physiotherapy
intervention type: Other
intervention name: Decongestive Physiotherapy plus taping
description: This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
arm group label: Decongestive Physiotherapy plus taping
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gülbin Ergin, PhD
role: Principal Investigator
affiliation: European University of Lefke
last name: Didem Karadibak, Prof.
role: Study Director
affiliation: Dokuz Eylul University
last name: Tuğba Yavuzşen, Prof.
role: Study Director
affiliation: Dokuz Eylul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Ertan Sahinoglu
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 