Objective: Advanced pneumatic compression devices (APCDs) have been shown to be an effective intervention for lymphedema when used as part of a self-care maintenance treatment regimen. However, adherence to self-care has been poor, and APCDs require patients to be immobile during treatment. We evaluated the safety and efficacy of a novel nonpneumatic compression device (NPCD) for treating lymphedema vs an APCD.
Methods: A randomized, crossover head-to-head investigation was performed at five U.S. sites in 2021. The patients had been randomized to either the NPCD or a commercially available APCD. The patients used the randomly assigned initial device for 28 days with a 4-week washout period before a comparable 28-day use of the second device.
Results: Data from 50 adult women with unilateral breast cancer-related lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean reduction in the limb edema volume (64.6% vs 27.7%; P < .001), significantly greater mean improvements in quality of life scores, greater adherence (95.6% vs 49.8%; P < .001), and greater satisfaction with the device (90% vs 14%; P < .001). The patients indicated that use of the NPCD facilitated exercise and was convenient for travel. No adverse events were reported.
Conclusions: The results have shown that the novel NPCD is an effective maintenance treatment for reducing the limb volume in patients with breast cancer-related lymphedema. The NPCD device was more effective than an APCD and resulted in greater adherence to self-care interventions and greater patient satisfaction.
Trial registration: ClinicalTrials.gov NCT04908254.
Keywords: Breast cancer-related lymphedema; Cancer survivorship; Medical device; Quality of life.
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.