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

Completed

• Conditions: Breast cancer associated lymphoedema; Circulatory System; Post-procedural disorders of the circulatory system, not elsewhere classified.

• Registration Number: ISRCTN76522412
• Lead Sponsor: Stanford University Institutional Review Board (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-11
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

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.

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration