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

Mette Brodersen Jerver

Status: Unknown

Conditions: Breast Cancer; Lymphedema

Treatments: Other: Educational information, recommendation and instruction; Device: Custom-made compression sleeve and -gauntlet

Study type: Interventional

Funder types: Other

Identifiers

NCT01954654

2007-58-0010 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Accelerated treatment

Experimental group

Treatment:

Other: Educational information, recommendation and instruction

Device: Custom-made compression sleeve and -gauntlet

Standard treatment

Active Comparator group

Treatment:

Other: Educational information, recommendation and instruction

Device: Custom-made compression sleeve and -gauntlet