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
Scientific
Stanford University
Falk Cardiovascular Research Center
Stanford, CA
94305
United States of America
| Phone | +1 650 725 7571 |
|---|---|
| srockson@cvmed.stanford.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | Prospective Randomised, Crossover Evaluation of the Flexitouch™ in comparison with standard treatment for Secondary Arm Lymphoedema |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2003 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Stanford University
Stanford, CA
94305
United States of America
94305
United States of America
Sponsor information
Stanford University Institutional Review Board (USA)
University/education
University/education
Stanford University
Research Compliance Office
1215 Welch Road, Modular A
Stanford, CA
94305
United States of America
"ROR" |
https://ror.org/00f54p054 |
|---|
Funders
Funder type
University/education
Stanford University (USA)
Government organisation / Universities (academic only)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
