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
Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema
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
Hospitals
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
Device
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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
Adult
Gender
Female
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
Funders
Funder type
University/education
Funder name
Stanford University (USA)
Alternative name(s)
SU
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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
Basic results (scientific)
Publication list
2006 results in: https://www.ncbi.nlm.nih.gov/16571129
Publication citations
-
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.