Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE).

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.