Lymphedema
Conditions
Keywords
secondary arm-lymphedema, breast cancer related arm-lymphedema
Brief summary
Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase 1. thesis: \- all types should be equal regarding volume reduction 2. thesis: armsleeves manufactured with microfibre yarn are expected to be * better in wearing comfort and * better in handling features.
Detailed description
1. thesis: * measuring of arm volume by inverse water-volumetry (see later) * measuring of circumference cD * measuring of circumference cG * photodocumentation in 2 positions(during each round) 2. thesis * questionaire for patients * in the beginning * after 1 week * after 2 weeks (at the end of a wearing period) * questionaire for study nurse (at the end of a wearing period)
Interventions
OTHERCompression Armsleeves
Type: Compression Class II (according to RAL) The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient.
Sponsors
KABEG Management
Nij Smellinghe Hosptial
Universitaire Ziekenhuizen KU Leuven
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with a secondary arm-lymphedema for at least 3 months * willingness to wear compression arm-sleeves for at least 12 hours per day * maintenance phase, where no significant further reduction of arm-volume can be achieved * lymphedema in stadium 1 or 2 * age: at least 18 years * signed consent form by the patient * sufficient knowledge in national language
Exclusion criteria
* edema not completely reduced to maintenance phase * immobilized patient * acute deep vein thrombosis in arm * directly after arm-vein-thrombosis * acute arm erysipelas * malignant edema * existent lipedema * arterial occlusion * distinctive neuropathy in upper limbs * neurinoma in upper limbs * chronic pain after plastic surgery in upper limbs, shoulder or breast * change in drug treatment, that can influence edema situation during the study * pregnant women * breast giving mothers * not signed consent form * participation in a second clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of volume (arm and hand together) | 6 weaks per patient | During a 2-weeks-phase the volume of patients arm and hand together is measured once a week, e.g. 3 times (beginning, after 1 week, at the end). This is done with armsleeves of the first type. After one week of sedation the test will be repeated with the second product. Randomization is given by chance, that during first phase product of type A or type B can be applied. During second phase then vice versa. The measurements were performed by an inverse water plethysmography device (later: inverse watervolumetry) desinged by R. Damstra. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical judgement of skin status | 6 weaks per patient | clinical judgement of skin status with photo documentation, clinical finding (as palpation,check on fibrosclerosis, skin clour, skin surface, edema, tenderness, tissue consistency...), check of skin contamination |
| Wearing comfort and handling features of armsleeves | 6 weeks per patient | For both types of products questionaires are prepared to find out how patients are feeling with their armsleeves.It is asked for problems during donning procedure as well as during wearing period. This will be done in the beginning after 1 week and after 2 weeks for both types. At the end the study nurses are asked to their impression regarding patients acceptance of the armsleeves. Method: VAS score |
Countries
Austria, Belgium, Germany, Netherlands
Contacts
Primary ContactMichael Jünger, Prof. Dr.
Backup ContactClaudia Eggert, Study Nurse
Outcome results
None listed