NCT01318785

Brief Summary

Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase

  • better in wearing comfort and
  • better in handling features.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

December 3, 2010

Last Update Submit

September 5, 2011

Conditions

Lymphedema

Keywords

secondary arm-lymphedemabreast cancer related arm-lymphedema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Clinical judgement of skin status

    6 weaks per patient

  • Wearing comfort and handling features of armsleeves

    6 weeks per patient

Study Arms (2)

Compression ArmsleevesType A

ACTIVE COMPARATOR

Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387

Other: Compression Armsleeves

Compression Armsleeves Type B

ACTIVE COMPARATOR

Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387

Other: Compression Armsleeves

Interventions

Compression ArmsleevesOTHER

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.

Also known as: Bauerfeind SoraLife, Jobst Elvarex
Compression Armsleeves Type BCompression ArmsleevesType A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Landeskrankenhaus Wolfsberg

Wolfsberg, Carinthia, 9400, Austria

RECRUITING

Universitaire Ziekenhuizen

Leuven, 3000, Belgium

RECRUITING

Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Nij Smellinghe Hosptial

Drachten, 9202, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

LymphedemaBreast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Jünger, Prof. Dr.

    Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Jünger, Prof. Dr.

CONTACT

+493834-866770juenger@uni-greifswald.de

Claudia Eggert, Study Nurse

CONTACT

+493834-866770claudia.eggert@uni-greifswald.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2010

First Posted

March 18, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

BE(1)AU(1)NL(1)DE(1)