Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema
NCT ID: NCT01954654
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Accelerated treatment
Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Standard treatment
Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Interventions
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Custom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
Educational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
95 Years
FEMALE
No
Sponsors
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Mette Brodersen Jerver
OTHER
Responsible Party
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Mette Brodersen Jerver
Physiotherapist
Locations
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Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen
Aarhus, Aarhus, Denmark
Countries
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Central Contacts
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Facility Contacts
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Mette B Jerver
Role: primary
Other Identifiers
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2007-58-0010
Identifier Type: -
Identifier Source: org_study_id