Breast cancer associated lymphoedema Circulatory System Post-procedural disorders of the circulatory system, not elsewhere classified.
Conditions
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
the initial modality of therapy was followed, after the washout phase, by crossover to the alternate treatment modality.
Sponsors
Stanford University Institutional Review Board (USA)
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United States of America
Outcome results
None listed