Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (BF09-PH-01)

Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)

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.

Study Overview

• Status: Unknown
• Conditions: Lymphedema
• Intervention / Treatment: Other: Compression Armsleeves

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)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Jünger, Prof. Dr.; Phone Number: +493834-866770; Email: juenger@uni-greifswald.de
• Study Contact Backup: Name: Claudia Eggert, Study Nurse; Phone Number: +493834-866770; Email: claudia.eggert@uni-greifswald.de

Study Locations

• Austria
  • Kärnten
    • Wolfsberg, Kärnten, Austria, 9400
      • Recruiting
      • Landeskrankenhaus Wolfsberg
      • Contact: Walter Döller, MD; Email: sekretariatlymph@lkh-wo.at
      • Principal Investigator: Walter Döller, MD
• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitaire Ziekenhuizen
    • Contact: Maria Flour, MD; Email: maria.flour@uz.kuleuven.ac.be
    • Principal Investigator: Maria Flour, MD
• Germany
  • Mecklenburg Vorpommern
    • Greifswald, Mecklenburg Vorpommern, Germany, 17475
      • Recruiting
      • Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
      • Contact: Michael Jünger, Prof. Dr.; Phone Number: +493834-866770; Email: juenger@uni-greifswald.de
      • Contact: Claudia Eggert, Study Nurse; Phone Number: +493834-866770; Email: claudia.eggert@uni-greifswald.de
• Netherlands
  • Drachten, Netherlands, 9202
    • Recruiting
    • Nij Smellinghe Hosptial
    • Contact: Robert Damstra, MD; Email: r.damstra@nijsmellinghe.nl
    • Principal Investigator: Robert Damstra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Compression ArmsleevesType A; Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387	Other: Compression 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.; Other Names: Bauerfeind SoraLife; Jobst Elvarex
ACTIVE_COMPARATOR: Compression Armsleeves Type B; Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387	Other: Compression 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.; Other Names: Bauerfeind SoraLife; Jobst Elvarex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of volume (arm and hand together)	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.	6 weaks per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical judgement of skin status	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	6 weaks per patient
Wearing comfort and handling features of armsleeves	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	6 weeks per patient

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Nij Smellinghe Hosptial; KABEG Management
• Investigators: Principal Investigator: Michael Jünger, Prof. Dr., Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald

Publications and helpful links

Helpful Links

• link to Greifswald dermatology

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): October 1, 2011
• Study Completion (ANTICIPATED): November 1, 2011

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (ESTIMATE): March 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 5, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: secondary arm-lymphedema; breast cancer related arm-lymphedema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: Multicentrestudy "BF09-PH-01"