Long-term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck...

We previously reported short-term (2 months) efficacy results of an advanced pneumatic compression device (APCD) versus usual care (UC) for the treatment of head and neck cancer survivors with symptomatic treatment-naive lymphedema (HNLEF). Herein we report the long-term (4 and 6 months) outcomes of that trial.

This multisite, prospective randomized clinical trial was conducted at academic and community-based sites. Eligibility criteria included: head and neck cancer survivors without evidence of cancer, previously untreated HNLEF evaluable on exam or imaging, and ≥1 associated symptom with severity of ≥4 out of 10. Participants were randomly assigned 1:1 to either daily use of an APCD for 6 months or UC per institutional standards. Measurement tools included: patient-reported outcome measures, Clinician-reported outcome (CRO) measures, digital photographs, and computed tomography (CT). Measures were at baseline, 2, 4 (no CT), and 6 months.

A total of 236 participants were enrolled (119 APCD, 117 UC). Tumor distribution by group was as follows: APCD = larynx 29.4%, salivary glands 1.7%, oral cavity 37.8%, paranasal sinuses 1.7%, pharynx 25.2%, unknown primary 4.2%; UC = larynx 16.2%, salivary glands 5.1%, oral cavity 48.7%, paranasal sinuses 1.7%, pharynx 21.4%, unknown primary 6.8%. Of the UC group, 17.1% (n = 20) underwent bilateral neck dissection, as did 12.6% (n = 15) of the APCD group. Symptom improvement garnered during initial treatment was maintained over time in both groups with no significant difference between groups. CRO measures demonstrated improvement in internal HNLEF (Modified Patterson Scale, P < .01 both groups) and external HNLEF (grading criteria, APCD P < .01; UC P = .06) in the APCD group. Statistically significant differences at 2 of 19 anatomic subsites favored the APCD group. At 6 months, the digital photography showed improvement with no between-group difference. CT findings at 6 months verified significant improvement in soft tissue swelling in both groups (P < .01 for both groups) that was not present at 2 months, with no between-group difference.

At 6 months, the analysis indicated that APCD and UC resulted in improved symptom control of similar magnitude. CROs, imaging, and digital photography demonstrated improvement in anatomic lymphedema in both groups over time. Select CRO outcome measures demonstrated marginal differences between groups that favored the APCD. Both interventions provided long-term benefit to patients with treatment-naive lymphedema.