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

Not Applicable

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

• Registration Number: NCT01954654
• Lead Sponsor: Mette Brodersen Jerver

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.

Study Timeline

• Study First Submitted: 2013-09-29
• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-04
• Last Update Submitted: 2013-10-06
• Study First Posted: 2013-10-07
• Last Update Posted: 2013-10-08
• Primary Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated treatment	Custom-made compression sleeve and -gauntlet	-
Accelerated treatment	Educational information, recommendation and instruction	-
Standard treatment	Custom-made compression sleeve and -gauntlet	-
Standard treatment	Educational information, recommendation and instruction	-

Primary Outcome Measures

Name	Time	Method
Change of excess limb volume (ELV)	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 Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen; 🇩🇰 Aarhus, Denmark