Treatment of Breast Cancer-Related Lymphedema with a Negative Pressure Device: A Pilot Randomized Controlled Study

Lampinen, R., Leano, J., Smoot, B., Mastick, J., Miaskowski, C., Brinker, L. & Lee, J. Q. Archives of Phydical Medication and Rehabilitation. April 2021.

Purpose/Hypothesis: 1 in 5 women develop lymphedema (LE) following breast cancer (BC) treatment. If untreated, LE may become chronic and result in persistent swelling, inflammation, skin thickening, and abnormal fibro-adipose tissue deposition. Current conservative treatments do not specifically address secondary soft tissue changes that may limit response to treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate efficacy of treatment for chronic LE using a negative-pressure device, which mobilizes skin and subcutaneous tissue to support lymphatic circulation.

Subjects: Data were analyzed for 28 women (informed consent provided) who were >1 year post active BC treatment and have had unilateral upper extremity LE for >1 year. Women were randomized into the negative-pressure device treatment group (n=14) or the manual lymphatic drainage (MLD) control group (n=14).

Material/methods: This study compared negative-pressure massage using the LymphaTouch device (Helsinki, Finland) to MLD. Both groups used the Vodder unilateral upper extremity LE sequence. All participants received twelve 1-hour treatments over 4 to 6 weeks. Patients completed demographic and clinical questionnaires, and the Disability of Arm, Shoulder, Hand (DASH). Objective measures included bioimpedance (L-Dex; Impedimed) and limb volume (ml) calculated from limb circumference. T-tests and ANOVA (General Linear Model–Repeated Measures) were used to evaluate within and betweengroup differences and interaction effects.

Results: Average age was 62.4 years (SD 12.3) and BMI was 29.0 (SD 9.6). Mean baseline interlimb volume difference (affected vs unaffected limbs) was 511.3 ml (SD 378.2) and L-Dex was 29.0 (SD 23.3). Differences between groups at baseline were not statistically significant for age (p=0.108), BMI (p=0.802), L-Dex (p=0.218), DASH (p=0.259) and interlimb volume difference (p=0.076). The LymphaTouch group demonstrated slightly greater improvement in L-Dex, volume, and DASH scores, compared to the MLD group. However, only the between-groups difference in the change in L-Dex reached statistical significance, favoring the LymphaTouch group (L-Dex change: MLD mean +2.79 L-DEX units, SD 5.08); LymphaTouch: mean -4.16 L-Dex units, SD 7.51; interaction p=0.008).

Conclusions: Treatment with the negative-pressure massage device resulted in statistically significantly greater improvement in L-Dex scores compared to MLD, in women with unilateral upper extremity LE of >1-year duration. Slightly, but not statistically significantly greater improvements were also observed in volume and self-reported function. Three adverse events were recorded during the study but all were deemed unrelated to the treatment.

Clinical Relevance: Further research is needed to identify effective treatments for chronic LE that addresses not only limb volume but also secondary soft tissue changes. This can improve our ability to offer targeted interventions and improve outcomes for patients impacted by breast cancer-related LE. Results from this pilot study will guide the development of a larger, hypothesis driven RCT.