Breast Cancer, Lymphedema
Conditions
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.
Interventions
DEVICECustom-made compression sleeve and -gauntlet
Device: Compression garments worn for a minimum of six hours per day
OTHEREducational information, recommendation and instruction
Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
Sponsors
Mette Brodersen Jerver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Denmark
Contacts
Primary ContactMette B Jerver
Outcome results
None listed