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

October 6, 2013 updated by: Mette Brodersen Jerver

Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
        • Contact:
        • Principal Investigator:
          • Mette B Jerver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment
Device: Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Other Names:
  • Jobst Elvarex
Other: Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Experimental: Accelerated treatment
Device: Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Other Names:
  • Jobst Elvarex
Other: Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of excess limb volume (ELV)
Time Frame: 8 weeks follow-up
ELV in the affected arm compared to the non-affected arm. ELV described as both absolute volume in ml and relative volume in percent
8 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in arm disability
Time Frame: 8 weeks follow-up
Measured with Disabilities of Arm, Shoulder, and Hand (DASH)
8 weeks follow-up
Changes in subjective symptoms (pain, tension, and heaviness)
Time Frame: 8 weeks follow-up
8 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mette Brodersen Jerver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

September 29, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 6, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-58-0010 (Other Identifier: Data tilsynet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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