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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Device: Custom-made compression sleeve and -gauntlet
* Other: Educational information, recommendation and instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |