A multisite randomized trial of an advanced pneumatic compression device vs usual care for head and neck cancer related lymphedema: Short-term results.

Abstract

6107 Background: Lymphedema is common in head and neck cancer survivors (HNCS). Published data indicate that an Advanced Pneumatic Compression Device (APCD) is an effective intervention for lymphedema refractory to Therapist Guided Lymphedema Treatment (TGLT). It may also address barriers to TGLT. We therefore conducted a study in which HNCS with previously untreated lymphedema were randomized to APCD or Usual Care. We report short-term, two-month outcomes. Methods: This was a six-month, multi-site (community/academic), stratified, randomized effectiveness trial. Eligible patients were lymphedema therapy naïve HNCS with internal or external lymphedema on exam or imaging and at least 1 moderate (≥ 4/10) lymphedema associated symptom. Participants were randomized (1:1) to APCD or Usual Care. Those randomized to APCD were to use the device for 32 minutes per day. Participants randomized to Usual Care were referred for lymphedema therapy per institutional standards. The primary outcome was improvement in lymphedema associated symptom severity. Additional outcomes included anatomical measures, patient reported biopsychosocial outcomes, barriers to care, and patient satisfaction. Results: 236 participants were enrolled (119 APCD group, 117 Usual Care group). At two-months there was a similar decrease in lymphedema associated symptom burden and internal soft tissue swelling in both groups. We demonstrated a statistically significant external soft tissue swelling benefit favoring the APCD group as measured by the Head and Neck Cancer Related Lymphedema and Fibrosis Grading score (p=0.016). Digital photography identified a reduction in number of grids with swelling (p=<0.001) in the APCD group only. No reduction of internal swelling was noted in either group by imaging measures. 95% of APCD participants and 71% of Usual Care participants received assigned therapy. Time to therapy initiation was 29.8 days (SD 23.5) for Usual Care and 17.86 days (SD 10.53) for APCD. Conclusions: We demonstrated that APCD therapy is an effective treatment modality in lymphedema therapy naïve HNCS. Furthermore, participants experienced significant barriers to TGLT which may be effectively addressed with use of the APCD. A hybrid multi-modal approach to treatment associated lymphedema may further optimize patient outcomes. Clinical trial information: NCT04797390 .