Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated treatment | Experimental |
| |
| Standard treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-made compression sleeve and -gauntlet | Device | Device: Compression garments worn for a minimum of six hours per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in arm disability | Measured with Disabilities of Arm, Shoulder, and Hand (DASH) | 8 weeks follow-up |
| Changes in subjective symptoms (pain, tension, and heaviness) | 8 weeks follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mette B Jerver | Contact | +45 78 46 22 10 | Mette.Brodersen.Jerver@auh.rm.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Fysioterapi- og Ergoterapisfdelingen | Recruiting | Aarhus | Aarhus | 8000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Educational information, recommendation and instruction | Other | Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided