Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT
Identifieur interne : 000E69 ( Pmc/Curation ); précédent : 000E68; suivant : 000E70Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT
Auteurs : S. Mestre [France] ; C. Calais ; G. Gaillard ; M. Nou ; M. Pasqualini [France] ; C. Ben Amor [France] ; I. Quere [France]Source :
- Supportive Care in Cancer [ 0941-4355 ] ; 2017.
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%),
Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient’s self-management.
Url:
DOI: 10.1007/s00520-017-3652-5
PubMed: 28281052
PubMed Central: 5486732
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S. Mestre<affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2097 0141</institution-id><institution-id institution-id-type="GRID">grid.121334.6</institution-id><institution>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992,</institution><institution>Montpellier 1, University,</institution></institution-wrap>Montpellier and Nimes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier and Nimes</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2097 0141</institution-id><institution-id institution-id-type="GRID">grid.121334.6</institution-id><institution>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992,</institution><institution>Montpellier 1, University,</institution></institution-wrap>Montpellier and Nimes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier and Nimes</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Clinical Investigation Center, INSERM CIC 1001,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Montpellier, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier</wicri:regionArea></affiliation>Le document en format XML
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Mestre</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2097 0141</institution-id><institution-id institution-id-type="GRID">grid.121334.6</institution-id><institution>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992,</institution><institution>Montpellier 1, University,</institution></institution-wrap>Montpellier and Nimes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier and Nimes</wicri:regionArea></affiliation></author><author><name sortKey="Calais, C" sort="Calais, C" uniqKey="Calais C" first="C." last="Calais">C. Calais</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation></author><author><name sortKey="Gaillard, G" sort="Gaillard, G" uniqKey="Gaillard G" first="G." last="Gaillard">G. Gaillard</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation></author><author><name sortKey="Nou, M" sort="Nou, M" uniqKey="Nou M" first="M." last="Nou">M. Nou</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation></author><author><name sortKey="Pasqualini, M" sort="Pasqualini, M" uniqKey="Pasqualini M" first="M." last="Pasqualini">M. Pasqualini</name><affiliation wicri:level="1"><nlm:aff id="Aff3">THUASNE, Levallois-Perret, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>THUASNE, Levallois-Perret</wicri:regionArea></affiliation></author><author><name sortKey="Ben Amor, C" sort="Ben Amor, C" uniqKey="Ben Amor C" first="C." last="Ben Amor">C. Ben Amor</name><affiliation wicri:level="1"><nlm:aff id="Aff3">THUASNE, Levallois-Perret, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>THUASNE, Levallois-Perret</wicri:regionArea></affiliation></author><author><name sortKey="Quere, I" sort="Quere, I" uniqKey="Quere I" first="I." last="Quere">I. Quere</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</nlm:aff><wicri:noCountry code="subfield">Cedex 5 France</wicri:noCountry></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2097 0141</institution-id><institution-id institution-id-type="GRID">grid.121334.6</institution-id><institution>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992,</institution><institution>Montpellier 1, University,</institution></institution-wrap>Montpellier and Nimes, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier and Nimes</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Clinical Investigation Center, INSERM CIC 1001,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Montpellier, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Montpellier</wicri:regionArea></affiliation></author></analytic><series><title level="j">Supportive Care in Cancer</title><idno type="ISSN">0941-4355</idno><idno type="eISSN">1433-7339</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p id="Par1">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.</p></sec><sec><title>Methods</title><p id="Par2">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.</p></sec><sec><title>Results</title><p id="Par3">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%), <italic>p</italic> = 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.</p></sec><sec><title>Conclusions</title><p id="Par4">Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient’s self-management.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Petrek, Ja" uniqKey="Petrek J">JA Petrek</name></author><author><name sortKey="Heelan, Mc" uniqKey="Heelan M">MC Heelan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Meric, F" uniqKey="Meric F">F Meric</name></author><author><name sortKey="Buchholz, Ta" uniqKey="Buchholz T">TA Buchholz</name></author><author><name sortKey="Mirza, Nq" uniqKey="Mirza N">NQ Mirza</name></author><author><name sortKey="Vlastos, G" uniqKey="Vlastos G">G Vlastos</name></author><author><name sortKey="Ames, Fc" uniqKey="Ames F">FC Ames</name></author><author><name sortKey="Ross, Mi" uniqKey="Ross M">MI Ross</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Clark, B" uniqKey="Clark B">B Clark</name></author><author><name sortKey="Sitzia, J" uniqKey="Sitzia J">J Sitzia</name></author><author><name sortKey="Harlow, W" uniqKey="Harlow W">W Harlow</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Campbell, Kl" uniqKey="Campbell K">KL Campbell</name></author><author><name sortKey="Pusic, Al" uniqKey="Pusic A">AL Pusic</name></author><author><name sortKey="Zucker, Ds" uniqKey="Zucker D">DS Zucker</name></author><author><name sortKey="Mcneely, Ml" uniqKey="Mcneely M">ML McNeely</name></author><author><name sortKey="Binkley, Jm" uniqKey="Binkley J">JM Binkley</name></author><author><name sortKey="Cheville, Al" uniqKey="Cheville A">AL Cheville</name></author><author><name sortKey="Harwood, Kj" uniqKey="Harwood K">KJ Harwood</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Paskett, Ed" uniqKey="Paskett E">ED Paskett</name></author><author><name sortKey="Dean, Ja" uniqKey="Dean J">JA Dean</name></author><author><name sortKey="Oliveri, Jm" uniqKey="Oliveri J">JM Oliveri</name></author><author><name sortKey="Harrop, Jp" uniqKey="Harrop J">JP Harrop</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cheville, Al" uniqKey="Cheville A">AL Cheville</name></author><author><name sortKey="Mcgarvey, Cl" uniqKey="Mcgarvey C">CL McGarvey</name></author><author><name sortKey="Petrek, Ja" uniqKey="Petrek J">JA Petrek</name></author><author><name sortKey="Russo, Sa" uniqKey="Russo S">SA Russo</name></author><author><name sortKey="Taylor, Me" uniqKey="Taylor M">ME Taylor</name></author><author><name sortKey="Thiadens, Sr" uniqKey="Thiadens S">SR Thiadens</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Vignes, S" uniqKey="Vignes S">S Vignes</name></author><author><name sortKey="Porcher, R" uniqKey="Porcher R">R Porcher</name></author><author><name sortKey="Arrault, M" uniqKey="Arrault M">M Arrault</name></author><author><name sortKey="Dupuy, A" uniqKey="Dupuy A">A Dupuy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Quere, I" uniqKey="Quere I">I Quéré</name></author><author><name sortKey="Presles, E" uniqKey="Presles E">E Presles</name></author><author><name sortKey="Coupe, M" uniqKey="Coupe M">M Coupe</name></author><author><name sortKey="Vignes, S" uniqKey="Vignes S">S Vignes</name></author><author><name sortKey="Vaillant, L" uniqKey="Vaillant L">L Vaillant</name></author><author><name sortKey="Eveno, D" uniqKey="Eveno D">D 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Support Care Cancer</journal-id><journal-id journal-id-type="iso-abbrev">Support Care Cancer</journal-id><journal-title-group><journal-title>Supportive Care in Cancer</journal-title></journal-title-group><issn pub-type="ppub">0941-4355</issn><issn pub-type="epub">1433-7339</issn><publisher><publisher-name>Springer Berlin Heidelberg</publisher-name><publisher-loc>Berlin/Heidelberg</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28281052</article-id><article-id pub-id-type="pmc">5486732</article-id><article-id pub-id-type="publisher-id">3652</article-id><article-id pub-id-type="doi">10.1007/s00520-017-3652-5</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0003-0500-6199</contrib-id><name><surname>Mestre</surname><given-names>S.</given-names></name><address><phone>+33467337028</phone><email>s-mestre@chu-montpellier.fr</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Calais</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Gaillard</surname><given-names>G.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Nou</surname><given-names>M.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Pasqualini</surname><given-names>M.</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Ben Amor</surname><given-names>C.</given-names></name><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Quere</surname><given-names>I.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref><xref ref-type="aff" rid="Aff4">4</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Internal and Vascular Medicine Department,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Hopital St-Eloi, 80 Ave Augustin Fliche, 34295 Montpellier, Cedex 5 France</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2097 0141</institution-id><institution-id institution-id-type="GRID">grid.121334.6</institution-id><institution>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992,</institution><institution>Montpellier 1, University,</institution></institution-wrap>Montpellier and Nimes, France</aff><aff id="Aff3"><label>3</label>THUASNE, Levallois-Perret, France</aff><aff id="Aff4"><label>4</label><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9961 060X</institution-id><institution-id institution-id-type="GRID">grid.157868.5</institution-id><institution>Clinical Investigation Center, INSERM CIC 1001,</institution><institution>Montpellier University Hospital,</institution></institution-wrap>Montpellier, France</aff></contrib-group><pub-date pub-type="epub"><day>9</day><month>3</month><year>2017</year></pub-date><pub-date pub-type="pmc-release"><day>9</day><month>3</month><year>2017</year></pub-date><pub-date pub-type="ppub"><year>2017</year></pub-date><volume>25</volume><issue>8</issue><fpage>2455</fpage><lpage>2462</lpage><history><date date-type="received"><day>10</day><month>10</month><year>2016</year></date><date date-type="accepted"><day>20</day><month>2</month><year>2017</year></date></history><permissions><copyright-statement>© The Author(s) 2017</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold> 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.</license-p></license></permissions><abstract id="Abs1"><sec><title>Purpose</title><p id="Par1">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.</p></sec><sec><title>Methods</title><p id="Par2">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.</p></sec><sec><title>Results</title><p id="Par3">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%), <italic>p</italic> = 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.</p></sec><sec><title>Conclusions</title><p id="Par4">Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient’s self-management.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Self-management</kwd><kwd>Lymphedema</kwd><kwd>Breast cancer</kwd><kwd>Volume</kwd><kwd>Compression</kwd><kwd>Maintenance</kwd></kwd-group><funding-group><award-group><funding-source><institution-wrap><institution-id institution-id-type="FundRef">http://dx.doi.org/10.13039/501100005261</institution-id><institution>Centre Hospitalier Régional Universitaire de Montpellier</institution></institution-wrap></funding-source></award-group><award-group><funding-source><institution>Laboratory Thuasne</institution></funding-source></award-group></funding-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer-Verlag GmbH Germany 2017</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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