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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954654
• Other study ID #: 2007-58-0010
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2013
• Last updated: October 6, 2013
• Start date: October 2013

Study information

• Verified date: October 2013
• Source: Aarhus University Hospital
• Contact: Mette B Jerver
• Phone: +45 78 46 22 10
• Email: Mette.Brodersen.Jerver[@]auh.rm.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Mette Brodersen Jerver

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in arm disability	Measured with Disabilities of Arm, Shoulder, and Hand (DASH)	8 weeks follow-up	No
Secondary	Changes in subjective symptoms (pain, tension, and heaviness)		8 weeks follow-up	No