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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
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 c...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486732/ https://www.ncbi.nlm.nih.gov/pubmed/28281052 http://dx.doi.org/10.1007/s00520-017-3652-5 |
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author | Mestre, S. Calais, C. Gaillard, G. Nou, M. Pasqualini, M. Ben Amor, C. Quere, I. |
author_facet | Mestre, S. Calais, C. Gaillard, G. Nou, M. Pasqualini, M. Ben Amor, C. Quere, I. |
author_sort | Mestre, S. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5486732 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-54867322017-07-11 Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT Mestre, S. Calais, C. Gaillard, G. Nou, M. Pasqualini, M. Ben Amor, C. Quere, I. Support Care Cancer Original Article 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. Springer Berlin Heidelberg 2017-03-09 2017 /pmc/articles/PMC5486732/ /pubmed/28281052 http://dx.doi.org/10.1007/s00520-017-3652-5 Text en © The Author(s) 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article Mestre, S. Calais, C. Gaillard, G. Nou, M. Pasqualini, M. Ben Amor, C. Quere, I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title | Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title_full | Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title_fullStr | Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title_full_unstemmed | Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title_short | Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT |
title_sort | interest of an auto-adjustable nighttime compression sleeve (mobiderm® autofit) in maintenance phase of upper limb lymphedema: the marilyn pilot rct |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486732/ https://www.ncbi.nlm.nih.gov/pubmed/28281052 http://dx.doi.org/10.1007/s00520-017-3652-5 |
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