Clinical trial NCT01318785: Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
Official title: Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphedema
Keywords: secondary arm-lymphedema
breast cancer related arm-lymphedema
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: KABEG Management
name: Nij Smellinghe Hosptial
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2011-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: change of volume (arm and hand together)
timeFrame: 6 weaks per patient
Secondary outcomes:
measure: Clinical judgement of skin status
timeFrame: 6 weaks per patient
measure: Wearing comfort and handling features of armsleeves
timeFrame: 6 weeks per patient
Other outcomes:
Locations:
city: Wolfsberg
country: Austria
facility: Landeskrankenhaus Wolfsberg
state: Kärnten
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen
city: Greifswald
country: Germany
facility: Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
state: Mecklenburg Vorpommern
city: Drachten
country: Netherlands
facility: Nij Smellinghe Hosptial
Study officials:
affiliation: Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald
name: Michael Jünger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: