<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/NCT03760744</url>
  </required_header>
  <id_info>
    <org_study_id>131172</org_study_id>
    <secondary_id>1R01NR015079</secondary_id>
    <nct_id>NCT03760744</nct_id>
  </id_info>
  <brief_title>Imaging Biomarkers of Lymphatic Dysfunction</brief_title>
  <official_title>Imaging Biomarkers of Lymphatic Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Persons with secondary arm and/or upper quadrant lymphedema following cancer therapies&#xD;
      commonly are prescribed complete decongestive therapy as a course of management of their&#xD;
      lymphedema. The investigators will perform a repeated-measures cross-over trial to test the&#xD;
      hypothesis that mobilization of protein enriched hardened tissue using graded negative&#xD;
      pressure therapy in conjunction with complete decongestive therapy (CDT) is more effective to&#xD;
      standard CDT alone for secondary lymphedema management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this work is to apply novel, noninvasive magnetic resonance imaging (MRI) methods&#xD;
      for visualizing lymphatic circulation dysfunction to test a fundamental hypothesis about&#xD;
      secondary lymphedema conservative decongestive therapy. Breast cancer treatment-related&#xD;
      lymphedema (BCRL) arises secondary to surgical axillary lymph node (LN) dissection and&#xD;
      irritation, and is a chronic and lifelong condition affecting a high 21.4% of patients&#xD;
      receiving common breast cancer therapies. Persons with secondary lymphedema following&#xD;
      axillary lymph node removal also include undergoing treatment for other cancers, such as&#xD;
      melanoma involving the upper body, necessitating the need for axially lymph node removal.&#xD;
&#xD;
      Improving lymphedema management represents a major clinical need, and emerging efforts focus&#xD;
      on improving quality of life through optimizing post-surgical complex decongestive therapy&#xD;
      (CDT), and exploring novel pharmacological and surgical procedures. Here, the investigators&#xD;
      will perform a repeated-measures cross-over trial to test the hypothesis that mobilization of&#xD;
      protein enriched hardened tissue using graded negative pressure therapy in conjunction with&#xD;
      complete decongestive therapy (CDT) is more effective to standard CDT alone for secondary&#xD;
      lymphedema management. Both of these conservative physical therapy treatments are commonly&#xD;
      employed for treatment of secondary lymphedema.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing a Change in Bioimpedance Spectroscopy (BIS)</measure>
    <time_frame>At baseline and at 6-8 weeks following the completion of each therapy</time_frame>
    <description>BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing a Change in Lymphatic Stasis</measure>
    <time_frame>At baseline and at 6-8 weeks following the completion of each therapy</time_frame>
    <description>Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing a Change in Limb Volume</measure>
    <time_frame>At baseline and at 6-8 weeks following the completion of each therapy</time_frame>
    <description>Volume quantified using Perometer at baseline and following course of each treatment (cross over design)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Secondary Lymphedema</condition>
  <arm_group>
    <arm_group_label>CDT with Negative Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDT alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CDT with Negative Pressure</intervention_name>
    <description>Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance</description>
    <arm_group_label>CDT with Negative Pressure</arm_group_label>
    <other_name>CDT with LymphaTouch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CDT alone</intervention_name>
    <description>Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance</description>
    <arm_group_label>CDT alone</arm_group_label>
    <other_name>Complete decongestive therapy without negative pressure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following&#xD;
             cancer treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have any type of non-MRI compatible bioimplant activated by mechanical,&#xD;
             electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators,&#xD;
             biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be&#xD;
             able to tolerate the limited fit of the MRI&#xD;
&#xD;
          -  Subjects who have any type of ferromagnetic bioimplant that could potentially be&#xD;
             displaced.&#xD;
&#xD;
          -  Subjects who may have shrapnel embedded in their bodies (such as from war wounds),&#xD;
             metal workers and machinists (potential for metallic fragments in or near the eyes).&#xD;
&#xD;
          -  Pregnant women will be excluded from the MRI portion of the study only&#xD;
&#xD;
          -  Subjects who have open wounds on either ankle or top of foot because of&#xD;
             contraindications with placement of electrodes to obtain the L-DEX U400 readings.&#xD;
&#xD;
          -  Persons with heart pacemakers.&#xD;
&#xD;
          -  Persons with bilateral arm lymphedema (or bilateral risk) or pre-existing&#xD;
             lymphedema/edema in the upper body prior to cancer treatments.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manus M Donahue, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paula M Donahue, DPT</last_name>
    <phone>615-343-0389</phone>
    <email>paula.m.donahue@vumc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria E Garza, BS</last_name>
    <email>maria.e.garza@vumc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Donahue PM, Crescenzi R, Scott AO, Braxton V, Desai A, Smith SA, Jordi J, Meszoely IM, Grau AM, Kauffmann RM, Sweeting RS, Spotanski K, Ridner SH, Donahue MJ. Bilateral Changes in Deep Tissue Environment After Manual Lymphatic Drainage in Patients with Breast Cancer Treatment-Related Lymphedema. Lymphat Res Biol. 2017 Mar;15(1):45-56. doi: 10.1089/lrb.2016.0020.</citation>
    <PMID>28323572</PMID>
  </reference>
  <reference>
    <citation>Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.</citation>
    <PMID>28245075</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Manus Donahue</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>lymphedema</keyword>
  <keyword>therapy</keyword>
  <keyword>swelling</keyword>
  <keyword>graded negative pressure</keyword>
  <keyword>complete decongestive therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</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/NCT03760744
org study id: 131172
secondary id: 1R01NR015079
nct id: NCT03760744
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Persons with secondary arm and/or upper quadrant lymphedema following cancer therapies
      commonly are prescribed complete decongestive therapy as a course of management of their
      lymphedema. The investigators will perform a repeated-measures cross-over trial to test the
      hypothesis that mobilization of protein enriched hardened tissue using graded negative
      pressure therapy in conjunction with complete decongestive therapy (CDT) is more effective to
      standard CDT alone for secondary lymphedema management.
The goal of this work is to apply novel, noninvasive magnetic resonance imaging (MRI) methods
      for visualizing lymphatic circulation dysfunction to test a fundamental hypothesis about
      secondary lymphedema conservative decongestive therapy. Breast cancer treatment-related
      lymphedema (BCRL) arises secondary to surgical axillary lymph node (LN) dissection and
      irritation, and is a chronic and lifelong condition affecting a high 21.4% of patients
      receiving common breast cancer therapies. Persons with secondary lymphedema following
      axillary lymph node removal also include undergoing treatment for other cancers, such as
      melanoma involving the upper body, necessitating the need for axially lymph node removal.

      Improving lymphedema management represents a major clinical need, and emerging efforts focus
      on improving quality of life through optimizing post-surgical complex decongestive therapy
      (CDT), and exploring novel pharmacological and surgical procedures. Here, the investigators
      will perform a repeated-measures cross-over trial to test the hypothesis that mobilization of
      protein enriched hardened tissue using graded negative pressure therapy in conjunction with
      complete decongestive therapy (CDT) is more effective to standard CDT alone for secondary
      lymphedema management. Both of these conservative physical therapy treatments are commonly
      employed for treatment of secondary lymphedema.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Assessing a Change in Bioimpedance Spectroscopy (BIS)
time frame: At baseline and at 6-8 weeks following the completion of each therapy
description: BIS quantified using Impedimed L-dex at baseline and following course of each treatment (cross over design)
measure: Assessing a Change in Lymphatic Stasis
time frame: At baseline and at 6-8 weeks following the completion of each therapy
description: Quantitative analysis of lymphatic stasis using non-invasive MR lymphangiography at baseline and following course of each treatment (cross over design)
measure: Assessing a Change in Limb Volume
time frame: At baseline and at 6-8 weeks following the completion of each therapy
description: Volume quantified using Perometer at baseline and following course of each treatment (cross over design)
arm group label: CDT with Negative Pressure
arm group type: Experimental
description: CDT with LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
arm group label: CDT alone
arm group type: Active Comparator
description: CDT alone without LymphaTouch for 6 weeks, total of 9 therapy visits (75minutes duration)
intervention type: Procedure
intervention name: CDT with Negative Pressure
description: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance
arm group label: CDT with Negative Pressure
other name: CDT with LymphaTouch
intervention type: Procedure
intervention name: CDT alone
description: Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
arm group label: CDT alone
other name: Complete decongestive therapy without negative pressure
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
last name: Manus M Donahue, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Paula M Donahue, DPT
phone: 615-343-0389
email: paula.m.donahue@vumc.org
last name: Maria E Garza, BS
email: maria.e.garza@vumc.org
facility: 
status: Recruiting
country: United States
citation: Donahue PM, Crescenzi R, Scott AO, Braxton V, Desai A, Smith SA, Jordi J, Meszoely IM, Grau AM, Kauffmann RM, Sweeting RS, Spotanski K, Ridner SH, Donahue MJ. Bilateral Changes in Deep Tissue Environment After Manual Lymphatic Drainage in Patients with Breast Cancer Treatment-Related Lymphedema. Lymphat Res Biol. 2017 Mar;15(1):45-56. doi: 10.1089/lrb.2016.0020.
PMID: 28323572
citation: Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.
PMID: 28245075
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Manus Donahue
investigator title: Associate Professor
mesh term: Lymphedema
sharing ipd: No