title: Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient's self-management.
authors.affiliation: Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France. s-mestre@chu-montpellier.fr.|Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992, Montpellier 1, University, Montpellier and Nimes, France. s-mestre@chu-montpellier.fr.
authors.forename: S
authors.identifier: 0000-0003-0500-6199
authors.initials: S
authors.lastname: Mestre
authors.affiliation: Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.
authors.forename: C
authors.initials: C
authors.lastname: Calais
authors.affiliation: Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.
authors.forename: G
authors.initials: G
authors.lastname: Gaillard
authors.affiliation: Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.
authors.forename: M
authors.initials: M
authors.lastname: Nou
authors.affiliation: THUASNE, Levallois-Perret, France.
authors.forename: M
authors.initials: M
authors.lastname: Pasqualini
authors.affiliation: THUASNE, Levallois-Perret, France.
authors.forename: C
authors.initials: C
authors.lastname: Ben Amor
authors.affiliation: Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.|Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992, Montpellier 1, University, Montpellier and Nimes, France.|Clinical Investigation Center, INSERM CIC 1001, Montpellier University Hospital, Montpellier, France.
authors.forename: I
authors.initials: I
authors.lastname: Quere
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008209:Lymphedema / Q000628:therapy*; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D012648:Self Care; D053828:Stockings, Compression / Q000706:statistics & numerical data*; D034941:Upper Extremity / Q000473:pathology*
keywords: Breast cancer; Compression; Lymphedema; Maintenance; Self-management; Volume