Welcome
Support Centre
01 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema
ISRCTN ISRCTN76522412
DOI 10.1186/ISRCTN76522412
ClinicalTrials.gov identifier
EudraCT number
Public title Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema
Scientific title
Acronym N/A
Serial number at source 79787
Study hypothesis Not provided at time of registration
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Breast cancer associated lymphoedema
Participants - inclusion criteria Patients with lymphoedema of the upper extremity after surgical and/or radiotherapeutic interventions for breast carcinoma were eligible for enrollment. Recruitment was undertaken from the population of patients who presented to the Stanford Center for Lymphatic and Venous Disorders.

Inclusion criteria:
To be eligible for enrollment, a subject was required to have evidence of unilateral, breast
cancer-associated lymphoedema, with an increase of at least 10% in the measured volume of the affected arm when compared with the contralateral, normal limb. All subjects were required to have completed an initial treatment phase of limb volume reduction through intensive decongestive physiotherapy administered by a trained physiotherapist. A minimum of 30 days must have elapsed following the completion of initial treatment, which was required to include instruction in self-administered, maintenance manual
lymphatic drainage (MLD) and the subsequent use of a properly fitted compression garment.
Participants - exclusion criteria Exclusion criteria included the presence of any of the following: bilateral lymphoedema of the upper extremity; active cancer; active infection; clinical evidence of venous obstruction or active thrombophlebitis; pulmonary oedema; congestive heart failure; a history of pulmonary embolism; or the presence of any other relative contraindication to
the use of the lymphedema treatment modalities employed in this investigation.
Anticipated start date 01/12/2003
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions The active treatment phases were comprised of maintenance therapy with the Flexitouch™ alone or with MLD alone, respectively, as an adjunct to the daily use of the compression garment. Each treatment modality was utilised for one hour daily during 14
consecutive days of treatment. Each phase of active treatment was preceded by a 1 week
treatment washout, with use of the garment alone (no MLD). The sequence of treatment was randomly assigned; the initial modality of therapy was followed, after the washout phase, by crossover to the alternate treatment modality.
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Stanford University (USA)
Trial website
Publications 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16571129
Contact name Prof  Stanley  Rockson
  Address Stanford University
Falk Cardiovascular Research Center
  City/town Stanford, CA
  Zip/Postcode 94305
  Country United States of America
  Tel +1 650 725 7571
  Fax +1 650 725 1599
  Email srockson@cvmed.stanford.edu
Sponsor Stanford University Institutional Review Board (USA)
  Address Stanford University
Research Compliance Office
1215 Welch Road, Modular A
  City/town Stanford, CA
  Zip/Postcode 94305
  Country United States of America
Date applied 11/05/2005
Last edited 16/08/2011
Date ISRCTN assigned 11/05/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.