Condition category
Circulatory System
Date applied
11/05/2005
Date assigned
11/05/2005
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stanley Rockson

ORCID ID

Contact details

Stanford University
Falk Cardiovascular Research Center
Stanford
CA
94305
United States of America
+1 650 725 7571
srockson@cvmed.stanford.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

79787

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Breast cancer associated lymphoedema

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2003

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant 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.

Recruitment start date

01/12/2003

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

Stanford University
Stanford, CA
94305
United States of America

Sponsor information

Organisation

Stanford University Institutional Review Board (USA)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Stanford University (USA)

Alternative name(s)

SU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16571129

Publication citations

  1. Results

    Wilburn O, Wilburn P, Rockson SG, A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]., BMC Cancer, 2006, 6, 84, doi: 10.1186/1471-2407-6-84.

Additional files

Editorial Notes