Short-Term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial.

Abstract

Two-month outcomes of advanced pneumatic compression device (APCD) and usual care (UC) in Head and Neck Cancer survivors with previously untreated lymphedema were compared. Participants in this multisite, randomized clinical trial were randomized to APCD or UC. The primary endpoint was severity of lymphedema symptoms. Secondary endpoints were anatomical lymphedema changes, biopsychosocial outcomes, and barriers to care. Two hundred thirty-six participants were enrolled (119 APCD, 117 UC). Analysis was intention-to-treat. Lymphedema-associated symptom burden measured using the VHNSS and LSIDS was improved to a similar degree in both groups. APCD demonstrated a statistically significant improvement in external soft tissue swelling assessed by digital photography. No difference in CT imaging measures of lymphedema was noted. UC participants experienced barriers to care. APCD is an effective treatment for lymphedema in HNCS. The APCD addresses clinically significant barriers to therapist guided treatment. A hybrid approach may be complementary and optimize patient outcomes. NCT04797390.