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

内容摘要

We previously reported short-term efficacy (2-months) results of an advanced pneumatic compression device (APCD) versus usual care (UC) for treatment of head and neck cancer survivors (HNCS) with symptomatic treatment na&#xef;ve lymphedema (HNLEF). Herein we report the long-term (4 & 6-month) outcomes of that trial. This multi-site, prospective randomized clinical trial was conducted at academic and community-based sites. Eligibility criteria included: HNCS without evidence of cancer, previously untreated HNLEF evaluable on exam or imaging, and at least 1 associated symptom with severity of &#x2265;4 out of 10. Participants were randomized 1:1 to either daily use of an APCD for 6-months or UC per institutional standards. Measurement tools included: Patient-reported outcome (PRO) measures, Clinician reported outcome (CRO) measures, digital photographs, and computed tomography (CT). Measures were at baseline 2, 4 (no CT) and 6-months. 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 neck bilateral 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 <0.01 both groups) and external HNLEF (grading criteria, APCD p<0.01; UC p=0.06) in the APCD group. Statistically significant differences at two 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<0.01 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 na&#xef;ve lymphedema. NCT04797390.