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

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: Breast Cancer; Lymphedema
• Intervention / Treatment: Device: Custom-made compression sleeve and -gauntlet; Other: Educational information, recommendation and instruction

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

• Study Contact: Name: Mette B Jerver; Phone Number: +45 78 46 22 10; Email: Mette.Brodersen.jerver@auh.rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
    • Contact: Mette B Jerver; Phone Number: +45 78 46 22 10; Email: Mette.Brodersen.jerver@auh.rm.dk
    • Principal Investigator: Mette B Jerver

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Mette Brodersen Jerver

Study record dates

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: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: 2007-58-0010 (Other Identifier: Data tilsynet)