<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/NCT02187289</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA CC-14-0066</org_study_id>
    <nct_id>NCT02187289</nct_id>
  </id_info>
  <brief_title>Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects</brief_title>
  <acronym>LYNC</acronym>
  <official_title>Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AHS Cancer Control Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cross Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AHS Cancer Control Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lymphedema (significant arm swelling on the surgical side) is one of the most common&#xD;
      complications following treatment for breast cancer. The impact of lymphedema is profound,&#xD;
      resulting in negative self image, increased anxiety and poorer quality of life. In time,&#xD;
      lymphedema can result in recurrent infections in the arm, functional impairment and pain.&#xD;
      Approximately 21% of women who undergo breast cancer treatment develop lymphedema.&#xD;
      Unfortunately this is a life-time condition which tends to worsen over time. Currently,&#xD;
      treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the&#xD;
      wearing of compression sleeves during the day for maintenance. This study hopes to show that&#xD;
      the addition of night-time compression creates a measurable reduction in arm volume and that&#xD;
      adding night-time compression to the standard care (daytime compression only) will produce&#xD;
      improvements in quality of life for breast cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of&#xD;
      of treated breast cancer patients. An initial intensive rehabilitative treatment is usually&#xD;
      prescribed to reduce the lymphedema, followed by a maintenance program using compression&#xD;
      sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due&#xD;
      to the potential tourniquet effect of the sleeve rolling up or bunching during the night.&#xD;
&#xD;
      Compression Bandages (short stretch, low elasticity) can be used at night but proper&#xD;
      application takes 20-30 minutes, require skill to apply properly and are costly. Various&#xD;
      types of night-compression system garments (NCSGs) have been designed as alternatives to&#xD;
      Compression Bandages (CB).&#xD;
&#xD;
      The objectives of this study are to determine:&#xD;
&#xD;
        1. Whether the addition of night-time compression (using CB or NCSG) to standard care&#xD;
           (daytime compression only) improves control of arm lymphedema.&#xD;
&#xD;
        2. Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment&#xD;
           compliance and patient independence than use of Compression Bandages.&#xD;
&#xD;
      The hypotheses are that:&#xD;
&#xD;
        1. Standard care plus the addition of NCSG will provide statistically significant&#xD;
           improvement in management of arm lymphedema volume compared to standard care alone at 12&#xD;
           weeks.&#xD;
&#xD;
        2. Standard care plus the addition of Compression Bandages will provide statistically&#xD;
           significant improved management of arm lymphedema volume compared to standard care alone&#xD;
           at 12 weeks.&#xD;
&#xD;
        3. Standard care plus the addition of NCSG will provide statistically significant benefit&#xD;
           in quality of life, sleep and self-efficacy over standard care plus Compression&#xD;
           Bandaging at 12 weeks.&#xD;
&#xD;
      Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression&#xD;
      Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12&#xD;
&#xD;
      All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 -&#xD;
      24).&#xD;
&#xD;
      Sample size = 40 participants per group, for a total of 120 patients at three sites.&#xD;
&#xD;
      Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure&#xD;
      central randomization service administered by the Clinical Trials Unit of the Cross Cancer&#xD;
      Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema&#xD;
      severity (i.e. mild versus moderate lymphedema as per the classification criteria of the&#xD;
      International Society of Lymphology).&#xD;
&#xD;
      Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and&#xD;
      compared to that of the unaffected arm. BIA measures the impedance of flow from a low&#xD;
      alternating electrical current that is applied to the body through a skin electrode. BIA&#xD;
      records impedance values for each limb and provides an index that correlates with&#xD;
      quantitative measurements of volume increase in limb size seen in the arm with lymphedema.&#xD;
      This measurement will provide information on extracellular fluid changes that complements the&#xD;
      data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation&#xD;
      (blinded) will perform the measurements of arm volume using the perometer, bioimpedance&#xD;
      analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary&#xD;
      intervention will be 12 weeks. Following the 12-week intervention period, participants in the&#xD;
      CB and standard care groups will be measured for a NCSG.&#xD;
&#xD;
      The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal&#xD;
      observational design and provide an opportunity to examine factors related to long-term&#xD;
      adherence to night-time compression. Lymphedema specific questionnaires and subject diary&#xD;
      will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep&#xD;
      disturbance, self-efficacy and treatment adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care plus Night-time Compression Bandages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Plus Night-time Compression System Garment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Night-time compression bandages</intervention_name>
    <description>Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.</description>
    <arm_group_label>Standard Care plus Night-time Compression Bandages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Compression Sleeve, daytime wear</intervention_name>
    <arm_group_label>Standard Care Plus Night-time Compression System Garment</arm_group_label>
    <arm_group_label>Standard Care plus Night-time Compression Bandages</arm_group_label>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Night-time Compression custom-made garment</intervention_name>
    <description>Standard Care plus night-time compression by a custom-made night time compression system garment.</description>
    <arm_group_label>Standard Care Plus Night-time Compression System Garment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of&#xD;
             200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)&#xD;
&#xD;
          -  Completion of all primary and adjuvant cancer treatments (with exception of endocrine&#xD;
             treatment) 1 month prior to randomization.&#xD;
&#xD;
          -  In or entering upon the maintenance phase of lymphedema treatment.&#xD;
&#xD;
          -  Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12&#xD;
             hour per day standard of care period&#xD;
&#xD;
          -  No current use of night-time compression (one month wash-out period before trial&#xD;
             entry)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or radiological evidence of active disease, either local or metastatic&#xD;
&#xD;
          -  History or clinical diagnosis of bilateral arm lymphedema&#xD;
&#xD;
          -  Anyone for whom compression is contraindicated, such as those with untreated&#xD;
             infections, skin irritations/rash, or thrombosis of the affected arm&#xD;
&#xD;
          -  Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive&#xD;
             disorder) which would preclude consent/adherence to the protocol&#xD;
&#xD;
          -  Unable to comply with the protocol, measurement and follow-up schedule due to factors&#xD;
             such as vacation during the study period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret McNeely, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cross Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount St. Joseph Hospital/Holy Family (MSJ/HF)</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5T 3N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NCSG</keyword>
  <keyword>Compression bandages</keyword>
  <keyword>devices</keyword>
  <keyword>Night time compression</keyword>
  <keyword>Breast cancer treatment side effects</keyword>
  <keyword>Compression therapy</keyword>
  <keyword>Reid Sleeve</keyword>
  <keyword>Comprefit</keyword>
  <keyword>Medassist</keyword>
  <keyword>Tribute</keyword>
  <keyword>Comprilan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>IPD will be available starting 6 months after publication with no defined end date.</ipd_time_frame>
    <ipd_access_criteria>Guest book - visitors can request the data from corresponding author.</ipd_access_criteria>
    <ipd_url>https://dataverse.library.ualberta.ca/</ipd_url>
  </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/NCT02187289
org study id: HREBA CC-14-0066
nct id: NCT02187289
lead sponsor: 
collaborator: 
has dmc: No
Lymphedema (significant arm swelling on the surgical side) is one of the most common
      complications following treatment for breast cancer. The impact of lymphedema is profound,
      resulting in negative self image, increased anxiety and poorer quality of life. In time,
      lymphedema can result in recurrent infections in the arm, functional impairment and pain.
      Approximately 21% of women who undergo breast cancer treatment develop lymphedema.
      Unfortunately this is a life-time condition which tends to worsen over time. Currently,
      treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the
      wearing of compression sleeves during the day for maintenance. This study hopes to show that
      the addition of night-time compression creates a measurable reduction in arm volume and that
      adding night-time compression to the standard care (daytime compression only) will produce
      improvements in quality of life for breast cancer survivors.
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of
      of treated breast cancer patients. An initial intensive rehabilitative treatment is usually
      prescribed to reduce the lymphedema, followed by a maintenance program using compression
      sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due
      to the potential tourniquet effect of the sleeve rolling up or bunching during the night.

      Compression Bandages (short stretch, low elasticity) can be used at night but proper
      application takes 20-30 minutes, require skill to apply properly and are costly. Various
      types of night-compression system garments (NCSGs) have been designed as alternatives to
      Compression Bandages (CB).

      The objectives of this study are to determine:

        1. Whether the addition of night-time compression (using CB or NCSG) to standard care
           (daytime compression only) improves control of arm lymphedema.

        2. Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment
           compliance and patient independence than use of Compression Bandages.

      The hypotheses are that:

        1. Standard care plus the addition of NCSG will provide statistically significant
           improvement in management of arm lymphedema volume compared to standard care alone at 12
           weeks.

        2. Standard care plus the addition of Compression Bandages will provide statistically
           significant improved management of arm lymphedema volume compared to standard care alone
           at 12 weeks.

        3. Standard care plus the addition of NCSG will provide statistically significant benefit
           in quality of life, sleep and self-efficacy over standard care plus Compression
           Bandaging at 12 weeks.

      Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression
      Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12

      All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 -
      24).

      Sample size = 40 participants per group, for a total of 120 patients at three sites.

      Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure
      central randomization service administered by the Clinical Trials Unit of the Cross Cancer
      Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema
      severity (i.e. mild versus moderate lymphedema as per the classification criteria of the
      International Society of Lymphology).

      Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and
      compared to that of the unaffected arm. BIA measures the impedance of flow from a low
      alternating electrical current that is applied to the body through a skin electrode. BIA
      records impedance values for each limb and provides an index that correlates with
      quantitative measurements of volume increase in limb size seen in the arm with lymphedema.
      This measurement will provide information on extracellular fluid changes that complements the
      data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation
      (blinded) will perform the measurements of arm volume using the perometer, bioimpedance
      analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary
      intervention will be 12 weeks. Following the 12-week intervention period, participants in the
      CB and standard care groups will be measured for a NCSG.

      The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal
      observational design and provide an opportunity to examine factors related to long-term
      adherence to night-time compression. Lymphedema specific questionnaires and subject diary
      will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep
      disturbance, self-efficacy and treatment adherence.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
time frame: 12 weeks
measure: Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
time frame: 12 weeks
arm group label: Standard care
arm group type: Active Comparator
description: Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)
arm group label: Standard Care plus Night-time Compression Bandages
arm group type: Experimental
description: Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.
arm group label: Standard Care Plus Night-time Compression System Garment
arm group type: Experimental
description: Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment
intervention type: Device
intervention name: Night-time compression bandages
description: Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.
arm group label: Standard Care plus Night-time Compression Bandages
intervention type: Device
intervention name: Compression Sleeve, daytime wear
arm group label: Standard Care Plus Night-time Compression System Garment
arm group label: Standard Care plus Night-time Compression Bandages
arm group label: Standard care
intervention type: Device
intervention name: Night-time Compression custom-made garment
description: Standard Care plus night-time compression by a custom-made night time compression system garment.
arm group label: Standard Care Plus Night-time Compression System Garment
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Margaret McNeely, PhD
role: Principal Investigator
affiliation: Cross Cancer Institute
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphedema
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: IPD will be available starting 6 months after publication with no defined end date.
ipd access criteria: Guest book - visitors can request the data from corresponding author.
ipd url: https://dataverse.library.ualberta.ca/