Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT.
Identifieur interne : 000314 ( PubMed/Curation ); précédent : 000313; suivant : 000315Interest 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 [France] ; G. Gaillard [France] ; M. Nou [France] ; M. Pasqualini [France] ; C. Ben Amor [France] ; I. Quere [France]Source :
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [ 1433-7339 ] ; 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.
DOI: 10.1007/s00520-017-3652-5
PubMed: 28281052
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Gaillard</name><affiliation wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author><author><name sortKey="Nou, M" sort="Nou, M" uniqKey="Nou M" first="M" last="Nou">M. Nou</name><affiliation wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></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:affiliation>THUASNE, Levallois-Perret, France.</nlm:affiliation><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:affiliation>THUASNE, Levallois-Perret, France.</nlm:affiliation><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 wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28281052</idno><idno type="pmid">28281052</idno><idno type="doi">10.1007/s00520-017-3652-5</idno><idno type="wicri:Area/PubMed/Corpus">000314</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000314</idno><idno type="wicri:Area/PubMed/Curation">000314</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000314</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT.</title><author><name sortKey="Mestre, S" sort="Mestre, S" uniqKey="Mestre S" first="S" last="Mestre">S. Mestre</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author><author><name sortKey="Calais, C" sort="Calais, C" uniqKey="Calais C" first="C" last="Calais">C. Calais</name><affiliation wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author><author><name sortKey="Gaillard, G" sort="Gaillard, G" uniqKey="Gaillard G" first="G" last="Gaillard">G. Gaillard</name><affiliation wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author><author><name sortKey="Nou, M" sort="Nou, M" uniqKey="Nou M" first="M" last="Nou">M. Nou</name><affiliation wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></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:affiliation>THUASNE, Levallois-Perret, France.</nlm:affiliation><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:affiliation>THUASNE, Levallois-Perret, France.</nlm:affiliation><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 wicri:level="1"><nlm:affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5</wicri:regionArea></affiliation></author></analytic><series><title level="j">Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer</title><idno type="eISSN">1433-7339</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28281052</PMID><DateCreated><Year>2017</Year><Month>03</Month><Day>10</Day></DateCreated><DateRevised><Year>2017</Year><Month>07</Month><Day>14</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1433-7339</ISSN><JournalIssue CitedMedium="Internet"><Volume>25</Volume><Issue>8</Issue><PubDate><Year>2017</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer</Title><ISOAbbreviation>Support Care Cancer</ISOAbbreviation></Journal><ArticleTitle>Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM® Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT.</ArticleTitle><Pagination><MedlinePgn>2455-2462</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s00520-017-3652-5</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">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.</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Our results suggest that MOBIDERM® Autofit offers clinical benefits during maintenance phase of lymphedema treatment and enhances patient's self-management.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mestre</LastName><ForeName>S</ForeName><Initials>S</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-0500-6199</Identifier><AffiliationInfo><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.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992, Montpellier 1, University, Montpellier and Nimes, France. s-mestre@chu-montpellier.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Calais</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gaillard</LastName><ForeName>G</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nou</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pasqualini</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>THUASNE, Levallois-Perret, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ben Amor</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>THUASNE, Levallois-Perret, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Quere</LastName><ForeName>I</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Internal and Vascular Medicine Department, Montpellier University Hospital, Hopital St-Eloi, 80 Ave Augustin Fliche, 34295, Montpellier, Cedex 5, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Female specificity of the dysfunctions of Vascular Interfaces Laboratory EA2992, Montpellier 1, University, Montpellier and Nimes, France.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Clinical Investigation Center, INSERM CIC 1001, Montpellier University Hospital, Montpellier, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>03</Month><Day>09</Day></ArticleDate></Article><MedlineJournalInfo><Country>Germany</Country><MedlineTA>Support Care Cancer</MedlineTA><NlmUniqueID>9302957</NlmUniqueID><ISSNLinking>0941-4355</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Cancer. 1998 Dec 15;83(12 Suppl American):2776-81</RefSource><PMID Version="1">9874397</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Breast Cancer Res Treat. 2002 Sep;75(1):87-9</RefSource><PMID Version="1">12500937</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Clin Oncol. 2012 Oct 20;30(30):3726-33</RefSource><PMID Version="1">23008299</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer. 2012 Apr 15;118(8 Suppl):2300-11</RefSource><PMID Version="1">22488704</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Surg Oncol. 2002 Jul;9(6):543-9</RefSource><PMID Version="1">12095969</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Semin Radiat Oncol. 2003 Jul;13(3):290-301</RefSource><PMID Version="1">12903017</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Oncology (Williston Park). 1997 Jan;11(1):99-109; discussion 110, 113-4</RefSource><PMID Version="1">9115856</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Support Care Cancer. 2011 Jul;19(7):935-40</RefSource><PMID Version="1">20495983</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Vasc Surg. 2009 May;49(5):1256-63</RefSource><PMID Version="1">19394553</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Mal Vasc. 2014 Jul;39(4):256-63</RefSource><PMID Version="1">24931830</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>QJM. 2005 May;98(5):343-8</RefSource><PMID Version="1">15820971</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Phys Med Rehabil. 2001 Dec;82(12):1639-44</RefSource><PMID Version="1">11733875</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Breast cancer</Keyword><Keyword MajorTopicYN="N">Compression</Keyword><Keyword MajorTopicYN="N">Lymphedema</Keyword><Keyword MajorTopicYN="N">Maintenance</Keyword><Keyword MajorTopicYN="N">Self-management</Keyword><Keyword MajorTopicYN="N">Volume</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>10</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>02</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>3</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>3</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>3</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28281052</ArticleId><ArticleId IdType="doi">10.1007/s00520-017-3652-5</ArticleId><ArticleId IdType="pii">10.1007/s00520-017-3652-5</ArticleId><ArticleId IdType="pmc">PMC5486732</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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