Final Analysis (NILE): A Randomized Control Cross-Over Clinical Study Comparing Dayspring: A Novel Wearable Compression Technology to Pneumatic Compression Device in the Treatment of Lymphedema

A prospective, multicenter, randomized controlled cross-over clinical study to evaluate the Dayspring nonpneumatic compression device (NPCD; Koya Medical, Oakland, CA) in contrast to an advanced pneumatic compression device (APCD). Fifty-two patients with breast cancer-related lymphedema were enrolled across six sites. Patients were randomized to receive home treatment with either the Dayspring system or the Flexitouch Plus (Tactile Medical, Minneapolis, MN) pneumatic pump. Limb volume, lymphoedema quality of life, and adherence to daily therapy were measured. Patients were nearly all female. At the final analysis, patients were found to have greater adherence with NPCD Dayspring (95.6%) in comparison to APCD use (49.8%). Patients also demonstrated a greater mean reduction in edema volume with Dayspring NPCD (63.3%) versus with APCD (27.7%). Additionally, greater mean improvements in lymphoedema quality of life scores and significantly greater satisfaction with the device (90% vs 14%) were observed. The Dayspring NPCD is an effective maintenance treatment for reducing limb volume in patients with breast cancer-related lymphedema. The device was found to be more effective than an APCD, and resulted in higher adherence and greater satisfaction.