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Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema

Primary Purpose

Breast Cancer, Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Custom-made compression sleeve and -gauntlet
Educational information, recommendation and instruction
Sponsored by
Mette Brodersen Jerver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment
  • Participants must be ≥ 2 months after chemo- and radiotherapy
  • Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema
  • Participants must be motivated for treatment with compression sleeve and -gauntlet
  • Participants live in and around Aarhus, Denmark

Exclusion Criteria:

  • Known metastatic disease
  • Contraindication for treatment with compression sleeve
  • Upper extremity deep venous thrombosis
  • Previously use of compression sleeve
  • Known contact allergy to latex
  • Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition

Sites / Locations

  • Aarhus University Hospital, Fysioterapi- og ErgoterapisfdelingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accelerated treatment

Standard treatment

Arm Description

Outcomes

Primary Outcome Measures

Change of excess limb volume (ELV)
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent

Secondary Outcome Measures

Changes in arm disability
Measured with Disabilities of Arm, Shoulder, and Hand (DASH)
Changes in subjective symptoms (pain, tension, and heaviness)

Full Information

First Posted
September 29, 2013
Last Updated
October 6, 2013
Sponsor
Mette Brodersen Jerver
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1. Study Identification

Unique Protocol Identification Number
NCT01954654
Brief Title
Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema
Official Title
Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mette Brodersen Jerver

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether accelerated treatment with custom-made compression sleeve is more effective than standard procedure in the treatment of mild and moderate arm lymphedema secondary to primary cancer treatment.
Detailed Description
Use of a custom-made compression sleeve is an initial treatment of mild and moderate arm lymphedema secondary to primary breast cancer treatment. The compression sleeve improves the flow of lymph fluid out of the arm, reduces the swelling, and prevents progression of the lymphedema in the future. Early intervention is recommended though early is not well-defined in literature. The purpose of this study is to evaluate reduction of excess limb volume and changes in arm disability and clinical symptoms in accelerated treatment with compression sleeve compared to standard treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Accelerated treatment
Arm Type
Experimental
Arm Title
Standard treatment
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Custom-made compression sleeve and -gauntlet
Other Intervention Name(s)
Jobst Elvarex
Intervention Description
Device: Compression garments worn for a minimum of six hours per day
Intervention Type
Other
Intervention Name(s)
Educational information, recommendation and instruction
Intervention Description
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Primary Outcome Measure Information:
Title
Change of excess limb volume (ELV)
Description
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
Time Frame
8 weeks follow-up
Secondary Outcome Measure Information:
Title
Changes in arm disability
Description
Measured with Disabilities of Arm, Shoulder, and Hand (DASH)
Time Frame
8 weeks follow-up
Title
Changes in subjective symptoms (pain, tension, and heaviness)
Time Frame
8 weeks follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be refered for the first time due to unilateral arm lymphedema secondary to primary unilateral breast cancer treatment Participants must be ≥ 2 months after chemo- and radiotherapy Participants must have ELV ≥10% and < 30% and/or > 2 cm difference between the circumference of the two arms at minimum one circumference due to lymphedema Participants must be motivated for treatment with compression sleeve and -gauntlet Participants live in and around Aarhus, Denmark Exclusion Criteria: Known metastatic disease Contraindication for treatment with compression sleeve Upper extremity deep venous thrombosis Previously use of compression sleeve Known contact allergy to latex Unable to fill in questionnaire and/or comply with treatment due to lacking Danish language skills, mental state or psychological condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette B Jerver
Phone
+45 78 46 22 10
Email
Mette.Brodersen.Jerver@auh.rm.dk
Facility Information:
Facility Name
Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette B Jerver
Phone
+45 78 46 22 10
Email
Mette.Brodersen.jerver@auh.rm.dk
First Name & Middle Initial & Last Name & Degree
Mette B Jerver

12. IPD Sharing Statement

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Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema

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