<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/NCT03284008</url>
  </required_header>
  <id_info>
    <org_study_id>IEO S721/412</org_study_id>
    <nct_id>NCT03284008</nct_id>
  </id_info>
  <brief_title>Assessing Efficacy of Axillary Web Syndrome Treatment</brief_title>
  <official_title>Assessing Efficacy of Axillary Web Syndrome Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione Umberto Veronesi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Institute of Oncology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is verify the effectiveness of manual maneuver associated with&#xD;
      stretching exercises in the treatment of Axillary Web Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment&#xD;
      for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with&#xD;
      incidence reported in literature between 28% and 72%. AWS could be described as a&#xD;
      thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery,&#xD;
      with the same characteristics of &quot;Mondor's disease&quot; diagnosed in post-traumatic and surgical&#xD;
      areas where is a large presence of veno-lymphatic capillaries.&#xD;
&#xD;
      The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete&#xD;
      regression happen in 3-6 months after the onset. The clinical signs frequently described are&#xD;
      pain and tension during movement in the axillary region, elbow, forearm and wrist, following&#xD;
      the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into&#xD;
      activities that require a moderate range of motion and could feel and see in the affected arm&#xD;
      cords similar to a tendon. Even if the impairment can cause disability for a limited period&#xD;
      of time, rehabilitation is usually advice to prevent further complications such as frozen&#xD;
      shoulder, articular impeachment syndrome and long-term chronic pain, complications that could&#xD;
      worsen patient's quality of life with a significant increase in costs and time to recovery.&#xD;
&#xD;
      Nowadays there are no studies in the literature that demonstrate the effectiveness of&#xD;
      physiotherapy in AWS, with just case reports describing different treatments techniques,&#xD;
      without a scientifically defined experimented rehabilitation protocol.&#xD;
&#xD;
      This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a&#xD;
      manual maneuver associated with stretching exercises in the treatment of AWS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2013</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 12, 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion change overtime</measure>
    <time_frame>Baseline, 7 days and 30 days after baseline measure</time_frame>
    <description>Range of motion measured with a handheld goniometer, in degrees.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lymphedema assessment</measure>
    <time_frame>3 years after baseline measure</time_frame>
    <description>Lymphedema measured with centimetric and constant dielectric method</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain change overtime</measure>
    <time_frame>Baseline, 7 days and 30 days after baseline measure</time_frame>
    <description>Pain measured with 0-10 numeric rate scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Axillary Web Syndrome</condition>
  <arm_group>
    <arm_group_label>Manual manoeuver + stretching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stretching exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive education to perform stretching exercises at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual manoeuver + stretching</intervention_name>
    <description>Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.</description>
    <arm_group_label>Manual manoeuver + stretching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>stretching exercise</intervention_name>
    <description>Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.</description>
    <arm_group_label>stretching exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients with age between 18 and 70 years old&#xD;
&#xD;
          -  Axillary dissection with or without plastic reconstruction with prothesis&#xD;
&#xD;
          -  Positive diagnose of axillary web syndrome.&#xD;
&#xD;
          -  Patients without mental or psychological problems which could affect the proposed&#xD;
             treatment execution.&#xD;
&#xD;
          -  Signed informed consensus form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic or acute upper limb pathology which could affect the proposed treatment&#xD;
             execution.&#xD;
&#xD;
          -  Patients with mental or psychological problems which could affect the proposed&#xD;
             treatment execution.&#xD;
&#xD;
          -  Plastic reconstruction with abdominal (DIEP or TRAM) and dorsal grafts or with&#xD;
             expander.&#xD;
&#xD;
          -  Previous head and neck, sentinel lymph node biopsy or axillary dissection surgery.&#xD;
&#xD;
          -  Previous breast, axillary or head and neck radiotherapy.&#xD;
&#xD;
          -  Halsted mastectomy.&#xD;
&#xD;
          -  Previous lymphedema.&#xD;
&#xD;
          -  Bilateral axillary dissection surgery&#xD;
&#xD;
          -  Physiotherapy treatment execute outside hospital during the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabio Sandrin</last_name>
    <role>Principal Investigator</role>
    <affiliation>European Institute of Oncolgy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Bergmann A, Mendes VV, de Almeida Dias R, do Amaral E Silva B, da Costa Leite Ferreira MG, Fabro EA. Incidence and risk factors for axillary web syndrome after breast cancer surgery. Breast Cancer Res Treat. 2012 Feb;131(3):987-92. doi: 10.1007/s10549-011-1805-7. Epub 2011 Oct 11.</citation>
    <PMID>21987036</PMID>
  </reference>
  <reference>
    <citation>Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.</citation>
    <PMID>17457830</PMID>
  </reference>
  <reference>
    <citation>Wariss BR, Costa RM, Pereira AC, Koifman RJ, Bergmann A. Axillary web syndrome is not a risk factor for lymphoedema after 10 years of follow-up. Support Care Cancer. 2017 Feb;25(2):465-470. doi: 10.1007/s00520-016-3424-7. Epub 2016 Oct 4.</citation>
    <PMID>27704260</PMID>
  </reference>
  <reference>
    <citation>Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.</citation>
    <PMID>19306057</PMID>
  </reference>
  <reference>
    <citation>Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.</citation>
    <PMID>11448437</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Neoplasm</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03284008
org study id: IEO S721/412
nct id: NCT03284008
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is verify the effectiveness of manual maneuver associated with
      stretching exercises in the treatment of Axillary Web Syndrome.
Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment
      for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with
      incidence reported in literature between 28% and 72%. AWS could be described as a
      thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery,
      with the same characteristics of "Mondor's disease" diagnosed in post-traumatic and surgical
      areas where is a large presence of veno-lymphatic capillaries.

      The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete
      regression happen in 3-6 months after the onset. The clinical signs frequently described are
      pain and tension during movement in the axillary region, elbow, forearm and wrist, following
      the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into
      activities that require a moderate range of motion and could feel and see in the affected arm
      cords similar to a tendon. Even if the impairment can cause disability for a limited period
      of time, rehabilitation is usually advice to prevent further complications such as frozen
      shoulder, articular impeachment syndrome and long-term chronic pain, complications that could
      worsen patient's quality of life with a significant increase in costs and time to recovery.

      Nowadays there are no studies in the literature that demonstrate the effectiveness of
      physiotherapy in AWS, with just case reports describing different treatments techniques,
      without a scientifically defined experimented rehabilitation protocol.

      This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a
      manual maneuver associated with stretching exercises in the treatment of AWS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Range of motion change overtime
time frame: Baseline, 7 days and 30 days after baseline measure
description: Range of motion measured with a handheld goniometer, in degrees.
measure: Lymphedema assessment
time frame: 3 years after baseline measure
description: Lymphedema measured with centimetric and constant dielectric method
measure: Pain change overtime
time frame: Baseline, 7 days and 30 days after baseline measure
description: Pain measured with 0-10 numeric rate scale
arm group label: Manual manoeuver + stretching
arm group type: Experimental
description: Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.
arm group label: stretching exercise
arm group type: Active Comparator
description: Patients will receive education to perform stretching exercises at home.
intervention type: Other
intervention name: Manual manoeuver + stretching
description: Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.
arm group label: Manual manoeuver + stretching
intervention type: Other
intervention name: stretching exercise
description: Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.
arm group label: stretching exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fabio Sandrin
role: Principal Investigator
affiliation: European Institute of Oncolgy
facility: 
country: Italy
citation: Bergmann A, Mendes VV, de Almeida Dias R, do Amaral E Silva B, da Costa Leite Ferreira MG, Fabro EA. Incidence and risk factors for axillary web syndrome after breast cancer surgery. Breast Cancer Res Treat. 2012 Feb;131(3):987-92. doi: 10.1007/s10549-011-1805-7. Epub 2011 Oct 11.
PMID: 21987036
citation: Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.
PMID: 17457830
citation: Wariss BR, Costa RM, Pereira AC, Koifman RJ, Bergmann A. Axillary web syndrome is not a risk factor for lymphoedema after 10 years of follow-up. Support Care Cancer. 2017 Feb;25(2):465-470. doi: 10.1007/s00520-016-3424-7. Epub 2016 Oct 4.
PMID: 27704260
citation: Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
PMID: 19306057
citation: Moskovitz AH, Anderson BO, Yeung RS, Byrd DR, Lawton TJ, Moe RE. Axillary web syndrome after axillary dissection. Am J Surg. 2001 May;181(5):434-9. doi: 10.1016/s0002-9610(01)00602-x.
PMID: 11448437
responsible party type: Sponsor
mesh term: Syndrome
sharing ipd: No