Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema

ISRCTN ISRCTN76522412
DOI https://doi.org/10.1186/ISRCTN76522412
Secondary identifying numbers 79787
Submission date
11/05/2005
Registration date
11/05/2005
Last edited
04/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stanley Rockson
Scientific

Stanford University
Falk Cardiovascular Research Center
Stanford, CA
94305
United States of America

Phone +1 650 725 7571
Email srockson@cvmed.stanford.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific titleProspective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer associated lymphoedema
InterventionThe 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.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2003
Completion date30/09/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients 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.
Key exclusion criteriaExclusion 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.
Date of first enrolment01/12/2003
Date of final enrolment30/09/2004

Locations

Countries of recruitment

  • United States of America

Study participating centre

Stanford University
Stanford, CA
94305
United States of America

Sponsor information

Stanford University Institutional Review Board (USA)
University/education

Stanford University
Research Compliance Office
1215 Welch Road, Modular A
Stanford, CA
94305
United States of America

ROR logo "ROR" https://ror.org/00f54p054

Funders

Funder type

University/education

Stanford University (USA)
Government organisation / Universities (academic only)
Alternative name(s)
Stanford, Leland Stanford Junior University, SU
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/03/2006 Yes No

Editorial Notes

04/10/2017: internal review.