<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/NCT02992782</url>
  </required_header>
  <id_info>
    <org_study_id>HREBA - CC 16-1026</org_study_id>
    <nct_id>NCT02992782</nct_id>
  </id_info>
  <brief_title>Decongestive Exercise and Compression for Breast Cancer Related Lymphedema Management</brief_title>
  <acronym>DREAM</acronym>
  <official_title>Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Pilot Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cross Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</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>
      Women who have undergone breast cancer surgery may develop swelling of the arm on the side&#xD;
      the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This&#xD;
      study will examine the effect of a 12-week decongestive progressive resistance exercise with&#xD;
      advanced compression on breast cancer related lymphedema. Our objective is to determine if&#xD;
      breast cancer survivors are willing and able to wear advanced compression while exercising&#xD;
      and if the combination will help to reduce their lymphedema. Twenty-four breast cancer&#xD;
      survivors from Edmonton, Alberta will be enrolled in the one-year long study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer.&#xD;
      Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy.&#xD;
      Compression therapy and exercise are commonly prescribed treatment to help reduce the arm&#xD;
      swelling and to maintain the result. The exercise that is usually prescribed for lymphedema&#xD;
      is called decongestive remedial exercise. It involves active, non-resisted movements that&#xD;
      follow a specific order from proximal to distal and back proximally. The exercises start at&#xD;
      the neck, move to the chest wall and then down the arm, and back.&#xD;
&#xD;
      Two different types of compression garments have been proposed to help reduce swelling when&#xD;
      women are exercising. One compression garment is made with a stiffer, less elastic type of&#xD;
      material and is called a &quot;flat-knit&quot; garment. The other garment, the &quot;Adjustable Compression&#xD;
      Wrap&quot; is a garment with an adjustable elastic strapping system that helps to reinforce the&#xD;
      compression on the arm. Recent research suggests that these specialized garments enhance the&#xD;
      muscle pump effect on lymph flow; however, no research has been conducted to test whether&#xD;
      this actually results in improvements in arm lymphedema volume.&#xD;
&#xD;
      Resistance exercise training helps to improve arm flexibility, strength, function, and&#xD;
      quality of life in breast cancer survivors. Recent evidence has shown that breast cancer&#xD;
      survivors with lymphedema, can safely perform resistance training (strength training),&#xD;
      however, there is no impact (better or worse) on arm lymphedema volume.&#xD;
&#xD;
      To date, no studies have been performed combining all potential therapeutic approaches for&#xD;
      lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and&#xD;
      compression therapy. Women in the experimental arms of this study will wear a compression&#xD;
      garment when performing progressive resistance exercise that follows the decongestive&#xD;
      sequence. We will examine the effect of the combined intervention on arm lymphedema volume,&#xD;
      function and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Actual">August 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arm Lymphedema Volume</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bioimpedance Analysis</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper body strength</measure>
    <time_frame>Change baseline to 12 weeks</time_frame>
    <description>One repetition maximum strength for bench press and seated row</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower body strength</measure>
    <time_frame>Change baseline to 12 weeks</time_frame>
    <description>One repetition maximum strength for leg press</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder range of motion</measure>
    <time_frame>Change baseline to 12 weeks</time_frame>
    <description>Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphedema International Classification of Functioning (LYMPH-ICF)</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>Lymphedema-specific quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rand Short-form (SF): 36</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>General health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Godin Leisure-time Questionnaire</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>Physical activity level in previous 4-week period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>Body mass index as calculated by body weight and height metrics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Image</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>Body Image and Relationship in past month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Composition</measure>
    <time_frame>Change baseline to 12-weeks</time_frame>
    <description>Magnetic Resonance Imaging: fat, water and muscle mass</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Neoplasm</condition>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Compression Garment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise and Adjustable Compression Wrap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Home program of decongestive exercise and daily use of a compression sleeve</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise and Compression Garment</intervention_name>
    <description>Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve</description>
    <arm_group_label>Exercise and Compression Garment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise and Adjustable Compression Wrap</intervention_name>
    <description>Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve</description>
    <arm_group_label>Exercise and Adjustable Compression Wrap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is a female with a history of breast cancer;&#xD;
&#xD;
          2. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node&#xD;
             dissection;&#xD;
&#xD;
          3. Has unilateral mild to moderate lymphedema of at least 200 ml or 10% inter-limb volume&#xD;
             difference or a maximum of 40% and/or minimal volume difference of 100 ml or 5% in&#xD;
             hand and forearm region;&#xD;
&#xD;
          4. Has chronic lymphedema, defined as lymphedema that has been present for at least 3&#xD;
             months;&#xD;
&#xD;
          5. Is in the lymphedema maintenance phase of conservative treatment;&#xD;
&#xD;
          6. Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to&#xD;
             wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of&#xD;
             pressure);&#xD;
&#xD;
          7. Is agreeable to discontinuing other lymphedema treatments, including manual lymph&#xD;
             drainage and intermittent pneumatic compression during the supervised intervention&#xD;
             period of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are undergoing or are scheduled for chemotherapy, radiotherapy or biological therapy;&#xD;
&#xD;
          2. Present with limb infection, deep vein thrombosis, cellulitis, or have active&#xD;
             metastatic disease;&#xD;
&#xD;
          3. Have any neurological, cognitive deficit or other uncontrolled health condition that&#xD;
             may interfere with assessment and/or the progressive resistance exercise training&#xD;
             intervention;&#xD;
&#xD;
          4. Have any contraindications related to wearing compression on the limb, including&#xD;
             arterial insufficiency or congestive heart failure;&#xD;
&#xD;
          5. Have a body mass index (BMI) greater than 40 kg/m2.&#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>Margaret L McNeely, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta/ Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>September 2, 2023</last_update_submitted>
  <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network</ipd_description>
    <ipd_time_frame>Not determined</ipd_time_frame>
    <ipd_access_criteria>Pending</ipd_access_criteria>
  </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/NCT02992782
org study id: HREBA - CC 16-1026
nct id: NCT02992782
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women who have undergone breast cancer surgery may develop swelling of the arm on the side
      the breast cancer occurred. If the swelling becomes chronic it is called lymphedema. This
      study will examine the effect of a 12-week decongestive progressive resistance exercise with
      advanced compression on breast cancer related lymphedema. Our objective is to determine if
      breast cancer survivors are willing and able to wear advanced compression while exercising
      and if the combination will help to reduce their lymphedema. Twenty-four breast cancer
      survivors from Edmonton, Alberta will be enrolled in the one-year long study.
Lymphedema is a swelling in the arm, chest wall and breast on the side of the breast cancer.
      Arm lymphedema develops as a result of breast cancer surgery and/ or radiation therapy.
      Compression therapy and exercise are commonly prescribed treatment to help reduce the arm
      swelling and to maintain the result. The exercise that is usually prescribed for lymphedema
      is called decongestive remedial exercise. It involves active, non-resisted movements that
      follow a specific order from proximal to distal and back proximally. The exercises start at
      the neck, move to the chest wall and then down the arm, and back.

      Two different types of compression garments have been proposed to help reduce swelling when
      women are exercising. One compression garment is made with a stiffer, less elastic type of
      material and is called a "flat-knit" garment. The other garment, the "Adjustable Compression
      Wrap" is a garment with an adjustable elastic strapping system that helps to reinforce the
      compression on the arm. Recent research suggests that these specialized garments enhance the
      muscle pump effect on lymph flow; however, no research has been conducted to test whether
      this actually results in improvements in arm lymphedema volume.

      Resistance exercise training helps to improve arm flexibility, strength, function, and
      quality of life in breast cancer survivors. Recent evidence has shown that breast cancer
      survivors with lymphedema, can safely perform resistance training (strength training),
      however, there is no impact (better or worse) on arm lymphedema volume.

      To date, no studies have been performed combining all potential therapeutic approaches for
      lymphedema management: resistance exercise, a therapeutic decongestive exercise sequence, and
      compression therapy. Women in the experimental arms of this study will wear a compression
      garment when performing progressive resistance exercise that follows the decongestive
      sequence. We will examine the effect of the combined intervention on arm lymphedema volume,
      function and quality of life.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Arm Lymphedema Volume
time frame: Change from baseline to 12 weeks
description: Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
measure: Bioimpedance Analysis
time frame: Change from baseline to 12 weeks
description: Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
measure: Upper body strength
time frame: Change baseline to 12 weeks
description: One repetition maximum strength for bench press and seated row
measure: Lower body strength
time frame: Change baseline to 12 weeks
description: One repetition maximum strength for leg press
measure: Shoulder range of motion
time frame: Change baseline to 12 weeks
description: Range of motion measured with goniometer: forward flexion, abduction, external, internal and horizontal abduction movements
measure: Lymphedema International Classification of Functioning (LYMPH-ICF)
time frame: Change baseline to 12-weeks
description: Lymphedema-specific quality of life
measure: Rand Short-form (SF): 36
time frame: Change baseline to 12-weeks
description: General health-related quality of life
measure: Godin Leisure-time Questionnaire
time frame: Change baseline to 12-weeks
description: Physical activity level in previous 4-week period
measure: Body composition
time frame: Change baseline to 12-weeks
description: Body mass index as calculated by body weight and height metrics
measure: Body Image
time frame: Change baseline to 12-weeks
description: Body Image and Relationship in past month
measure: Tissue Composition
time frame: Change baseline to 12-weeks
description: Magnetic Resonance Imaging: fat, water and muscle mass
arm group label: Standard Care
arm group type: Active Comparator
description: Standard care Intervention: including a home program of therapeutic (decongestive) exercise, which will include active, non-resistive motion of the involved limb. Participants will perform the exercise once daily for about 10 minutes and will be required to wear their compression sleeve for at least 12 hours per day, each day of the week. After 24 weeks, they will be given the opportunity to take part in the decongestive progressive resistance exercise program and will be provided with an adjustable compression garment to use during exercise.
arm group label: Exercise and Compression Garment
arm group type: Experimental
description: Intervention will include having participants wear a compression sleeve during exercise. They will wear the sleeve while carrying out the decongestive progressive resistance exercise program and will continue wearing their day-time compression garment for at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 Weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness center or at home.
arm group label: Exercise and Adjustable Compression Wrap
arm group type: Experimental
description: Intervention will include having participants will be fitted for an adjustable compression wrap. They will be required to wear the adjustable compression wrap during the decongestive progressive resistance exercise program and will continue wearing their compression sleeve at least 12 hours per day, each day of the week. They will attend a supervised decongestive progressive resistance exercise program twice a week for 12 weeks at the Cancer Rehabilitation Clinic in Corbett Hall at the University of Alberta. Exercise session will take approximately 60-90 minutes. After 12 weeks, participants will continue the same program twice weekly for an additional 12 weeks in a community-based fitness centre or at home.
intervention type: Behavioral
intervention name: Standard Care
description: Home program of decongestive exercise and daily use of a compression sleeve
arm group label: Standard Care
intervention type: Behavioral
intervention name: Exercise and Compression Garment
description: Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
arm group label: Exercise and Compression Garment
intervention type: Behavioral
intervention name: Exercise and Adjustable Compression Wrap
description: Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
arm group label: Exercise and Adjustable Compression Wrap
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret L McNeely, PhD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
sharing ipd: Yes
ipd description: On completion of the study, data will be made available through the University of Alberta Libraries Dataserve Network
ipd time frame: Not determined
ipd access criteria: Pending