Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT

S. Mestre, C. Calais, G. Gaillard, M. Nou, M. Pasqualini, C. Ben Amor, I. Quere. Support Care Cancer (2017) 25:2455–2462.

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Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT

S. Mestre, C. Calais, G. Gaillard, M. Nou, M. Pasqualini, C. Ben Amor, I. Quere. Support Care Cancer (2017) 25:2455–2462.

PURPOSE:

Breast cancer-related lymphedema (BCRL) is a debilitating condition. The recommended treatment is based on decongestive lymphedema therapy (DLT) with two separate phases: a short-term intensive phase to reduce lymphedema volume and a long-term maintenance phase to stabilize it. Optimizing compression therapy and compliance during maintenance phase are key factors for long-term control of lymphedema. The primary objective of this pilot prospective open-label randomized study was to assess the benefit of a new auto-adjustable nighttime arm sleeve (MOBIDERM® Autofit) on lymphedema volume during the maintenance phase after the intensive phase.

METHODS:

Forty women with BRCL were consecutively enrolled and randomized (D0) for 1 month in 1:1 ratio either in night-use group: with MOBIDERM® Autofit (on top of a daytime compression hosiery), or in no night-use group: without MOBIDERM® Autofit (daytime hosiery alone). From Day 31 to Day 90, all patients were fitted with MOBIDERM® Autofit. Primary endpoint was lymphedema volume variation between Day 0 and Day 30. Secondary endpoints were compliance, quality of life (LYMQOL arm questionnaire), functional symptoms (heaviness, limb use limitation, pain), sleep quality, and safety.

RESULTS:

In ITT population, between Day 0 and Day 30, mean lymphedema volume increase was higher in no night-use group with 92.9 mL (i.e., 3.2%) than in night-use group with 46.7 mL (i.e., 1.80%), p = 0.757. Between Day 30 and Day 90, all patients fitted with MOBIDERM® Autofit, lymphedema volume remained stable in both groups. The device improved functional symptoms and function domain of the LYMQOL arm questionnaire. MOBIDERM® Autofit was worn overnight almost 85% of the nights. It was well accepted by the patients and no adverse reaction leading to permanent device discontinuation occurred.

CONCLUSIONS:

Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient’s self-management.

Main findings

  • At the end of the intensive phase of decongestive lymphatic therapy (day 0), patients were randomized in a 1:1 ratio to:
    • The night-use group (Group I), fitted during the first 30 days with MOBIDERM® Autofit device additionally to their daytime elastic hosiery.
    • The night-use group (Group II), fitted only with the day time elastic hosiery.
    • The daytime elastic hosiery was standardized. It was a circular made to measure knitted garment applying a level of pressure of 15–20 mmHg (French class 2) or 20– 36mmHg (French class 3) on investigator’s demand from THUASNE company (THUASNE Lymphology®).
  • The lymphedema volume variation from Day 0 to Day 30 was lower in patients fitted with MOBIDERM® Autofit (night use group) vs. the no night-use group (1.8 vs. 3.2%, respectively).
  • From Day 30 to Day 90, when all patients were fitted with the auto-adjustable MOBIDERM® Autofit arm sleeve during the night, the lymphedema volume remained stable in both groups, suggesting that the device allowed stabilization of the lymphedema volume as soon as it is putted on.
  • The stabilization observed in night-use group is associated with improvement of the functional symptoms as well as the function as assessed by the patients.
    • During the first month, MOBIDERM® Autofit was worn all night long for a mean of 84.5% of the nights. The same levels of compliance are observed from D30 to D90 in both groups, confirming the high acceptability of the device by patients.