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

Overview

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.

Full Title of Study: “Effectiveness of Accelerated Intervention With Custom-made Compression Sleeve in Women With Mild and Moderate Arm Lymphedema Secondary to Breast Cancer Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2015

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.

Interventions

  • Device: Custom-made compression sleeve and -gauntlet
    • Device: Compression garments worn for a minimum of six hours per day
  • Other: Educational information, recommendation and instruction
    • Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow

Arms, Groups and Cohorts

  • Experimental: Accelerated treatment
  • Active Comparator: Standard treatment

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mette Brodersen Jerver
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Mette Brodersen Jerver, Physiotherapist – Aarhus University Hospital
  • Overall Contact(s)
    • Mette B Jerver, +45 78 46 22 10, Mette.Brodersen.Jerver@auh.rm.dk

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