<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/NCT04435639</url>
  </required_header>
  <id_info>
    <org_study_id>ITSligo SG</org_study_id>
    <nct_id>NCT04435639</nct_id>
  </id_info>
  <brief_title>Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema</brief_title>
  <official_title>Can an Adjustable Compression Garment Replace Compression Bandaging in the Treatment of Patients With Breast Cancer Related Upper Limb Lymphoedema? A Pilot RCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Technology, Sligo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sligo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Technology, Sligo</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>
      This is a pilot randomised controlled trial investigating the use of an adjustable&#xD;
      compression garment in the treatment of patients with Breast Cancer related upper limb&#xD;
      Lymphoedema. This study will be conducted as part of a MSc qualification at the Institute of&#xD;
      Technology Sligo in Ireland with all therapy sessions taking place in the Physiotherapy&#xD;
      Department of Sligo University Hospital (formerly Sligo General Hospital). The study will be&#xD;
      conducted in conjunction with Sligo University Hospital and it has attained ethical approval&#xD;
      through the relevant University Hospital Ethics Committee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The experimental group will receive 5 treatments followed by a final assessment on the 6th&#xD;
      visit over a 3 week period: participants will receive manual lymphatic drainage for 40&#xD;
      minutes. They will then put on an Adjustable Compression sleeve (Juzo varocare adjustable&#xD;
      compression system). Patients will be re-measured before the fourth treatment and again on&#xD;
      session 6. At this point patients will receive a standard arm compression sleeve. This will&#xD;
      be worn in alternation with their adjustable compression sleeve over the following 6 months.&#xD;
      Patient will have their limb volume re-measured at the 6 month review.&#xD;
&#xD;
      The control group will receive 5 treatments followed by a final assessment on the 6th visit&#xD;
      over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes.&#xD;
      They will then have their arm wrapped in Coban compression bandaging which will stay on until&#xD;
      their next treatment. This will occur twice weekly for a period of 3 weeks. Patients will be&#xD;
      Re-measured before the fourth treatment and again on session 6. At this point they will&#xD;
      attend occupational therapy where they will receive 2 standard arm compression sleeves. The&#xD;
      patient wears 1 sleeve every day over the following 6 months. Patient will have their limb&#xD;
      volume re-measured at the 6 month review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 30, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</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>
    <intervention_model_description>Pilot Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor was blinded to treatment allocation. They evaluated participant's prior to treatment commencing and after treatment has been completed and compression garment/ compression bandaging has been removed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Limb Volume - Circumferential Measurements.</measure>
    <time_frame>Over a 6 month period. (10 min testing time)</time_frame>
    <description>Limb Volume- circumferential measurements taken at 4cm intervals from the wrist up to the axilla.&#xD;
The circumferences were then entered into a spreadsheet and a truncated cone formula applied with each segment volume calculated: Vs = h(Ct x Ct + Ct x Cb x Cb) 12 π&#xD;
where (Vs) was volume of a segment, (h) was the distance between two points of measurement, (Ct) represented the circumference at the top measurements of the segment, (Cb) represented the circumference at the base of the segment, π = Pi. Once each segment is calculated, the sum of all segments of the arm are computed into a volume estimate. This method was found to be valid (criterion validity)in several studies when compared to the gold standard of water displacement with intra-class correlation coefficient (ICC) of &gt;0.95. The higher the score the more lymphoedema present.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Form 36 (SF-36): Quality of Life questionnaire.</measure>
    <time_frame>Over a 6 month period. (10 min testing time)</time_frame>
    <description>SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting for routine monitoring and assessment of care outcomes in adult patients.It is scored 0-100 with a lower score indicating more disability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lymphedema of Upper Arm</condition>
  <arm_group>
    <arm_group_label>MLD + Adjustable Compression Sleeve.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymph drainage + Adjustable Compression Sleeve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MLD + Coban Compression Bandage.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Manual lymphatic drainage + Coban compression bandaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual lymph drainage.</intervention_name>
    <description>Manual Lymphatic drainage:&#xD;
Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.</description>
    <arm_group_label>MLD + Adjustable Compression Sleeve.</arm_group_label>
    <arm_group_label>MLD + Coban Compression Bandage.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coban compression bandage..</intervention_name>
    <description>Coban compression bandaging: Patients will be wrapped in Coban compression bandaging which stays on until the next treatment. Patients will wear standard compression sleeves during the six month maintenance phase.</description>
    <arm_group_label>MLD + Coban Compression Bandage.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adjustable Compression Sleeve</intervention_name>
    <description>Patients wear an adjustable compression sleeve (Juzo varocare adjustable compression system) between treatments. They will be shown how to put it on and how to tighten the sleeve when needed. Patients will also wear the adjustable compression sleeve in alternation with a standard compression sleeve over a six month maintenance phase.</description>
    <arm_group_label>MLD + Adjustable Compression Sleeve.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper limb lymphoedema (secondary to breast cancer) diagnosed by a consultant&#xD;
&#xD;
          -  Aged &gt; 18 years.&#xD;
&#xD;
          -  Males and females.&#xD;
&#xD;
          -  Stage 2 Lymphoedema.&#xD;
&#xD;
          -  &gt;10% volume difference between upper limbs.&#xD;
&#xD;
          -  Cognitive ability to understand the programme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Involvement in other studies or rehabilitation programmes.&#xD;
&#xD;
          -  Active infection disease progression.&#xD;
&#xD;
          -  Congestive Cardiac Failure.&#xD;
&#xD;
          -  Non-English speakers.&#xD;
&#xD;
          -  Under 18's.&#xD;
&#xD;
          -  Poor cognition for treatment compliance or consent.&#xD;
&#xD;
          -  Pregnant, or currently breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shane Gallagher, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kenneth Monaghan, PhD</last_name>
    <phone>0879480448</phone>
    <email>monaghan.kenneth@itsligo.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shane Gallagher, MSc</last_name>
  </overall_contact_backup>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer related lymphoedema.</keyword>
  <keyword>Compression bandaging.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04435639/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04435639/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04435639/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04435639
org study id: ITSligo SG
nct id: NCT04435639
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot randomised controlled trial investigating the use of an adjustable
      compression garment in the treatment of patients with Breast Cancer related upper limb
      Lymphoedema. This study will be conducted as part of a MSc qualification at the Institute of
      Technology Sligo in Ireland with all therapy sessions taking place in the Physiotherapy
      Department of Sligo University Hospital (formerly Sligo General Hospital). The study will be
      conducted in conjunction with Sligo University Hospital and it has attained ethical approval
      through the relevant University Hospital Ethics Committee.
The experimental group will receive 5 treatments followed by a final assessment on the 6th
      visit over a 3 week period: participants will receive manual lymphatic drainage for 40
      minutes. They will then put on an Adjustable Compression sleeve (Juzo varocare adjustable
      compression system). Patients will be re-measured before the fourth treatment and again on
      session 6. At this point patients will receive a standard arm compression sleeve. This will
      be worn in alternation with their adjustable compression sleeve over the following 6 months.
      Patient will have their limb volume re-measured at the 6 month review.

      The control group will receive 5 treatments followed by a final assessment on the 6th visit
      over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes.
      They will then have their arm wrapped in Coban compression bandaging which will stay on until
      their next treatment. This will occur twice weekly for a period of 3 weeks. Patients will be
      Re-measured before the fourth treatment and again on session 6. At this point they will
      attend occupational therapy where they will receive 2 standard arm compression sleeves. The
      patient wears 1 sleeve every day over the following 6 months. Patient will have their limb
      volume re-measured at the 6 month review.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot Randomised Controlled Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessor was blinded to treatment allocation. They evaluated participant's prior to treatment commencing and after treatment has been completed and compression garment/ compression bandaging has been removed.
measure: Limb Volume - Circumferential Measurements.
time frame: Over a 6 month period. (10 min testing time)
description: Limb Volume- circumferential measurements taken at 4cm intervals from the wrist up to the axilla.
The circumferences were then entered into a spreadsheet and a truncated cone formula applied with each segment volume calculated: Vs = h(Ct x Ct + Ct x Cb x Cb) 12 π
where (Vs) was volume of a segment, (h) was the distance between two points of measurement, (Ct) represented the circumference at the top measurements of the segment, (Cb) represented the circumference at the base of the segment, π = Pi. Once each segment is calculated, the sum of all segments of the arm are computed into a volume estimate. This method was found to be valid (criterion validity)in several studies when compared to the gold standard of water displacement with intra-class correlation coefficient (ICC) of >0.95. The higher the score the more lymphoedema present.
measure: Short Form 36 (SF-36): Quality of Life questionnaire.
time frame: Over a 6 month period. (10 min testing time)
description: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting for routine monitoring and assessment of care outcomes in adult patients.It is scored 0-100 with a lower score indicating more disability.
arm group label: MLD + Adjustable Compression Sleeve.
arm group type: Experimental
description: Manual lymph drainage + Adjustable Compression Sleeve.
arm group label: MLD + Coban Compression Bandage.
arm group type: Active Comparator
description: Manual lymphatic drainage + Coban compression bandaging.
intervention type: Other
intervention name: Manual lymph drainage.
description: Manual Lymphatic drainage:
Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.
arm group label: MLD + Adjustable Compression Sleeve.
arm group label: MLD + Coban Compression Bandage.
intervention type: Procedure
intervention name: Coban compression bandage..
description: Coban compression bandaging: Patients will be wrapped in Coban compression bandaging which stays on until the next treatment. Patients will wear standard compression sleeves during the six month maintenance phase.
arm group label: MLD + Coban Compression Bandage.
intervention type: Device
intervention name: Adjustable Compression Sleeve
description: Patients wear an adjustable compression sleeve (Juzo varocare adjustable compression system) between treatments. They will be shown how to put it on and how to tighten the sleeve when needed. Patients will also wear the adjustable compression sleeve in alternation with a standard compression sleeve over a six month maintenance phase.
arm group label: MLD + Adjustable Compression Sleeve.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shane Gallagher, MSc
role: Principal Investigator
affiliation: Study Principal Investigator
last name: Kenneth Monaghan, PhD
phone: 0879480448
email: monaghan.kenneth@itsligo.ie
last name: Shane Gallagher, MSc
responsible party type: Sponsor
mesh term: Lymphedema
provided document: 
provided document: 
provided document: 