Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial
Identifieur interne : 002D15 ( Istex/Corpus ); précédent : 002D14; suivant : 002D16Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial
Auteurs : Nele Devoogdt ; Marie-Rose Christiaens ; Inge Geraerts ; Steven Truijen ; Ann Smeets ; Karin Leunen ; Patrick Neven ; Marijke Van KampenSource :
- BMJ [ 0959-8138 ] ; 2011.
Abstract
Objective To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer. Design Randomised single blinded controlled trial. Setting University Hospitals Leuven, Leuven, Belgium. Participants 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups. Intervention For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage. Main outcome measures Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery. Results Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30). Conclusion Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.
Url:
DOI: 10.1136/bmj.d5326
Links to Exploration step
ISTEX:6083A6D89AE737BACDB31E790579C486B3899350Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title><author><name sortKey="Devoogdt, Nele" sort="Devoogdt, Nele" uniqKey="Devoogdt N" first="Nele" last="Devoogdt">Nele Devoogdt</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: nele.devoogdt@uzleuven.be</mods:affiliation></affiliation></author><author><name sortKey="Christiaens, Marie Rose" sort="Christiaens, Marie Rose" uniqKey="Christiaens M" first="Marie-Rose" last="Christiaens">Marie-Rose Christiaens</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Geraerts, Inge" sort="Geraerts, Inge" uniqKey="Geraerts I" first="Inge" last="Geraerts">Inge Geraerts</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Truijen, Steven" sort="Truijen, Steven" uniqKey="Truijen S" first="Steven" last="Truijen">Steven Truijen</name><affiliation><mods:affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</mods:affiliation></affiliation></author><author><name sortKey="Smeets, Ann" sort="Smeets, Ann" uniqKey="Smeets A" first="Ann" last="Smeets">Ann Smeets</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Leunen, Karin" sort="Leunen, Karin" uniqKey="Leunen K" first="Karin" last="Leunen">Karin Leunen</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Van Kampen, Marijke" sort="Van Kampen, Marijke" uniqKey="Van Kampen M" first="Marijke" last="Van Kampen">Marijke Van Kampen</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:6083A6D89AE737BACDB31E790579C486B3899350</idno><date when="2011" year="2011">2011</date><idno type="doi">10.1136/bmj.d5326</idno><idno type="url">https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">002D15</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">002D15</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title><author><name sortKey="Devoogdt, Nele" sort="Devoogdt, Nele" uniqKey="Devoogdt N" first="Nele" last="Devoogdt">Nele Devoogdt</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: nele.devoogdt@uzleuven.be</mods:affiliation></affiliation></author><author><name sortKey="Christiaens, Marie Rose" sort="Christiaens, Marie Rose" uniqKey="Christiaens M" first="Marie-Rose" last="Christiaens">Marie-Rose Christiaens</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Geraerts, Inge" sort="Geraerts, Inge" uniqKey="Geraerts I" first="Inge" last="Geraerts">Inge Geraerts</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Truijen, Steven" sort="Truijen, Steven" uniqKey="Truijen S" first="Steven" last="Truijen">Steven Truijen</name><affiliation><mods:affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</mods:affiliation></affiliation></author><author><name sortKey="Smeets, Ann" sort="Smeets, Ann" uniqKey="Smeets A" first="Ann" last="Smeets">Ann Smeets</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Leunen, Karin" sort="Leunen, Karin" uniqKey="Leunen K" first="Karin" last="Leunen">Karin Leunen</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation></affiliation></author><author><name sortKey="Van Kampen, Marijke" sort="Van Kampen, Marijke" uniqKey="Van Kampen M" first="Marijke" last="Van Kampen">Marijke Van Kampen</name><affiliation><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">BMJ</title><title level="j" type="abbrev">BMJ</title><idno type="ISSN">0959-8138</idno><idno type="eISSN">1468-5833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2011">2011</date><biblScope unit="volume">343</biblScope></imprint><idno type="ISSN">0959-8138</idno></series><idno type="istex">6083A6D89AE737BACDB31E790579C486B3899350</idno><idno type="DOI">10.1136/bmj.d5326</idno><idno type="href">bmj-343-bmj-d5326.pdf</idno><idno type="ArticleID">devn830802</idno><idno type="local">bmj;343/sep01_1/d5326</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0959-8138</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Objective To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer. Design Randomised single blinded controlled trial. Setting University Hospitals Leuven, Leuven, Belgium. Participants 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups. Intervention For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage. Main outcome measures Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery. Results Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30). Conclusion Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.</div></front></TEI><istex><corpusName>bmj</corpusName><keywords><teeft><json:string>lymphoedema</json:string><json:string>breast cancer</json:string><json:string>axillary</json:string><json:string>manual lymph drainage</json:string><json:string>guideline</json:string><json:string>exercise therapy</json:string><json:string>control group</json:string><json:string>intervention group</json:string><json:string>node</json:string><json:string>lymph</json:string><json:string>point prevalence</json:string><json:string>reprint</json:string><json:string>lymphedema</json:string><json:string>leuven</json:string><json:string>radiotherapy</json:string><json:string>randomised</json:string><json:string>cumulative incidence</json:string><json:string>randomisation</json:string><json:string>lymph drainage</json:string><json:string>axillary lymph node dissection</json:string><json:string>axilla</json:string><json:string>first year</json:string><json:string>axillary surgery</json:string><json:string>odds ratio</json:string><json:string>large effect</json:string><json:string>preventive effect</json:string><json:string>surgery</json:string><json:string>research table</json:string><json:string>axillary dissection</json:string><json:string>cumulative incidence rate</json:string><json:string>healthy side</json:string><json:string>measurement points</json:string><json:string>physical health</json:string><json:string>university hospitals leuven</json:string><json:string>breast lymphedema</json:string><json:string>secondary outcome parameters</json:string><json:string>unilateral axillary lymph node dissection</json:string><json:string>confidence interval</json:string><json:string>survival analyses</json:string><json:string>week treatment period</json:string><json:string>breast surgery</json:string><json:string>manual drainage</json:string><json:string>breast</json:string><json:string>circumference</json:string><json:string>dissection</json:string></teeft></keywords><author><json:item><name>Nele Devoogdt</name><affiliations><json:string>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</json:string><json:string>Department of Health Care, Artesis University College of Antwerp, Antwerp</json:string><json:string>E-mail: nele.devoogdt@uzleuven.be</json:string></affiliations></json:item><json:item><name>Marie-Rose Christiaens</name><affiliations><json:string>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</json:string></affiliations></json:item><json:item><name>Inge Geraerts</name><affiliations><json:string>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</json:string></affiliations></json:item><json:item><name>Steven Truijen</name><affiliations><json:string>Department of Health Care, Artesis University College of Antwerp, Antwerp</json:string></affiliations></json:item><json:item><name>Ann Smeets</name><affiliations><json:string>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</json:string></affiliations></json:item><json:item><name>Karin Leunen</name><affiliations><json:string>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</json:string></affiliations></json:item><json:item><name>Patrick Neven</name><affiliations><json:string>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</json:string></affiliations></json:item><json:item><name>Marijke Van Kampen</name><affiliations><json:string>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</json:string></affiliations></json:item></author><articleId><json:string>devn830802</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><abstract>Objective To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer. Design Randomised single blinded controlled trial. Setting University Hospitals Leuven, Leuven, Belgium. Participants 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups. Intervention For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage. Main outcome measures Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery. Results Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30). Conclusion Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.</abstract><qualityIndicators><score>8.5</score><pdfVersion>1.4</pdfVersion><pdfPageSize>595.276 x 841.89 pts (A4)</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>2273</abstractCharCount><pdfWordCount>5781</pdfWordCount><pdfCharCount>37864</pdfCharCount><pdfPageCount>12</pdfPageCount><abstractWordCount>328</abstractWordCount></qualityIndicators><title>Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title><genre><json:string>research-article</json:string></genre><host><title>BMJ</title><language><json:string>unknown</json:string></language><issn><json:string>0959-8138</json:string></issn><eissn><json:string>1468-5833</json:string></eissn><publisherId><json:string>bmj</json:string></publisherId><volume>343</volume><genre><json:string>journal</json:string></genre></host><categories><wos></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>general & internal medicine</json:string></scienceMetrix><inist><json:string>sciences appliquees, technologies et medecines</json:string><json:string>sciences biologiques et medicales</json:string><json:string>sciences medicales</json:string></inist></categories><publicationDate>2011</publicationDate><copyrightDate>2011</copyrightDate><doi><json:string>10.1136/bmj.d5326</json:string></doi><id>6083A6D89AE737BACDB31E790579C486B3899350</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>British Medical Journal Publishing Group</publisher><availability status="free"><p>Open Access</p></availability><date>2011</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title><author xml:id="author-1" corresp="yes"><persName><forename type="first">Nele</forename><surname>Devoogdt</surname></persName><email>nele.devoogdt@uzleuven.be</email><note type="biography">doctor in rehabilitation science</note><affiliation>doctor in rehabilitation science</affiliation><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation><affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</affiliation></author><author xml:id="author-2"><persName><forename type="first">Marie-Rose</forename><surname>Christiaens</surname></persName><note type="biography">professor, breast surgeon, and coordinator</note><affiliation>professor, breast surgeon, and coordinator</affiliation><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation></author><author xml:id="author-3"><persName><forename type="first">Inge</forename><surname>Geraerts</surname></persName><note type="biography">research fellow</note><affiliation>research fellow</affiliation><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation></author><author xml:id="author-4"><persName><forename type="first">Steven</forename><surname>Truijen</surname></persName><note type="biography">scientific coordinator</note><affiliation>scientific coordinator</affiliation><affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</affiliation></author><author xml:id="author-5"><persName><forename type="first">Ann</forename><surname>Smeets</surname></persName><note type="biography">breast surgeon</note><affiliation>breast surgeon</affiliation><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation></author><author xml:id="author-6"><persName><forename type="first">Karin</forename><surname>Leunen</surname></persName><note type="biography">gynaecological oncologist</note><affiliation>gynaecological oncologist</affiliation><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation></author><author xml:id="author-7"><persName><forename type="first">Patrick</forename><surname>Neven</surname></persName><note type="biography">professor in gynaecological oncology</note><affiliation>professor in gynaecological oncology</affiliation><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation></author><author xml:id="author-8"><persName><forename type="first">Marijke</forename><surname>Van Kampen</surname></persName><note type="biography">professor in rehabilitation science</note><affiliation>professor in rehabilitation science</affiliation><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation></author></analytic><monogr><title level="j">BMJ</title><title level="j" type="abbrev">BMJ</title><idno type="pISSN">0959-8138</idno><idno type="eISSN">1468-5833</idno><imprint><publisher>British Medical Journal Publishing Group</publisher><date type="published" when="2011"></date><biblScope unit="volume">343</biblScope></imprint></monogr><idno type="istex">6083A6D89AE737BACDB31E790579C486B3899350</idno><idno type="DOI">10.1136/bmj.d5326</idno><idno type="href">bmj-343-bmj-d5326.pdf</idno><idno type="ArticleID">devn830802</idno><idno type="local">bmj;343/sep01_1/d5326</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Objective To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer. Design Randomised single blinded controlled trial. Setting University Hospitals Leuven, Leuven, Belgium. Participants 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups. Intervention For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage. Main outcome measures Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery. Results Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30). Conclusion Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.</p></abstract></profileDesc><revisionDesc><change when="2011">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">bmj</journal-id><journal-id journal-id-type="nlm-ta">BMJ</journal-id><journal-id journal-id-type="publisher-id">bmj</journal-id><journal-title>BMJ</journal-title><abbrev-journal-title abbrev-type="publisher">BMJ</abbrev-journal-title><issn pub-type="ppub">0959-8138</issn><issn pub-type="epub">1468-5833</issn><publisher><publisher-name>British Medical Journal Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">devn830802</article-id><article-id pub-id-type="doi">10.1136/bmj.d5326</article-id><article-id pub-id-type="other">bmj;343/sep01_1/d5326</article-id><article-id pub-id-type="other">bmj;bmj.d5326</article-id><article-id pub-id-type="other">sep01_1</article-id><article-id pub-id-type="other">bmj.d5326</article-id><article-id pub-id-type="other">bmj.d5326</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research</subject></subj-group></article-categories><title-group><article-title>Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Devoogdt</surname><given-names>Nele</given-names></name><role>doctor in rehabilitation science</role><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Christiaens</surname><given-names>Marie-Rose</given-names></name><role>professor, breast surgeon, and coordinator</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Geraerts</surname><given-names>Inge</given-names></name><role>research fellow</role><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Truijen</surname><given-names>Steven</given-names></name><role>scientific coordinator</role><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Smeets</surname><given-names>Ann</given-names></name><role>breast surgeon</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Leunen</surname><given-names>Karin</given-names></name><role>gynaecological oncologist</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Neven</surname><given-names>Patrick</given-names></name><role>professor in gynaecological oncology</role><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author" corresp="no"><name><surname>Van Kampen</surname><given-names>Marijke</given-names></name><role>professor in rehabilitation science</role><xref ref-type="aff" rid="aff1">1</xref></contrib><aff id="aff1"><label>1</label>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</aff><aff id="aff2"><label>2</label>Department of Health Care, Artesis University College of Antwerp, Antwerp</aff><aff id="aff3"><label>3</label>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</aff></contrib-group><author-notes><corresp>Correspondence to: N Devoogdt <email>nele.devoogdt@uzleuven.be</email></corresp></author-notes><pub-date pub-type="collection"><year>2011</year></pub-date><pub-date pub-type="epub-original"><year>2011</year></pub-date><volume>343</volume><volume-id pub-id-type="other">343</volume-id><volume-id pub-id-type="other">343</volume-id><elocation-id>d5326</elocation-id><history><date date-type="accepted"><day>21</day><month>July</month><year>2011</year></date></history><permissions><copyright-statement>© Devoogdt et al 2011</copyright-statement><copyright-year>2011</copyright-year><copyright-holder>Devoogdt et al</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/"><p>This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/</ext-link> and <ext-link xlink:href="http://creativecommons.org/licenses/by-nc/2.0/legalcode" ext-link-type="uri">http://creativecommons.org/licenses/by-nc/2.0/legalcode</ext-link>.</p></license></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="bmj-343-bmj-d5326.pdf"></self-uri><abstract><p><bold>Objective</bold> To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer.</p><p><bold>Design</bold> Randomised single blinded controlled trial.</p><p><bold>Setting</bold> University Hospitals Leuven, Leuven, Belgium.</p><p><bold>Participants</bold> 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups.</p><p><bold>Intervention</bold> For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage.</p><p><bold>Main outcome measures</bold> Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery.</p><p><bold>Results</bold> Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30).</p><p><bold>Conclusion</bold> Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term.</p><p><bold>Trial registration</bold> Netherlands Trial Register No NTR 1055.</p></abstract></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial</title></titleInfo><name type="personal" displayLabel="corresp"><namePart type="given">Nele</namePart><namePart type="family">Devoogdt</namePart><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation><affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</affiliation><affiliation>E-mail: nele.devoogdt@uzleuven.be</affiliation><description>doctor in rehabilitation science</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marie-Rose</namePart><namePart type="family">Christiaens</namePart><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation><description>professor, breast surgeon, and coordinator</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Inge</namePart><namePart type="family">Geraerts</namePart><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation><description>research fellow</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Steven</namePart><namePart type="family">Truijen</namePart><affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</affiliation><description>scientific coordinator</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ann</namePart><namePart type="family">Smeets</namePart><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation><description>breast surgeon</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karin</namePart><namePart type="family">Leunen</namePart><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation><description>gynaecological oncologist</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Patrick</namePart><namePart type="family">Neven</namePart><affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</affiliation><description>professor in gynaecological oncology</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marijke</namePart><namePart type="family">Van Kampen</namePart><affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</affiliation><description>professor in rehabilitation science</description><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>British Medical Journal Publishing Group</publisher><dateIssued encoding="w3cdtf">2011</dateIssued><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Objective To determine the preventive effect of manual lymph drainage on the development of lymphoedema related to breast cancer. Design Randomised single blinded controlled trial. Setting University Hospitals Leuven, Leuven, Belgium. Participants 160 consecutive patients with breast cancer and unilateral axillary lymph node dissection. The randomisation was stratified for body mass index (BMI) and axillary irradiation and treatment allocation was concealed. Randomisation was done independently from recruitment and treatment. Baseline characteristics were comparable between the groups. Intervention For six months the intervention group (n=79) performed a treatment programme consisting of guidelines about the prevention of lymphoedema, exercise therapy, and manual lymph drainage. The control group (n=81) performed the same programme without manual lymph drainage. Main outcome measures Cumulative incidence of arm lymphoedema and time to develop arm lymphoedema, defined as an increase in arm volume of 200 mL or more in the value before surgery. Results Four patients in the intervention group and two in the control group were lost to follow-up. At 12 months after surgery, the cumulative incidence rate for arm lymphoedema was comparable between the intervention group (24%) and control group (19%) (odds ratio 1.3, 95% confidence interval 0.6 to 2.9; P=0.45). The time to develop arm lymphoedema was comparable between the two group during the first year after surgery (hazard ratio 1.3, 0.6 to 2.5; P=0.49). The sample size calculation was based on a presumed odds ratio of 0.3, which is not included in the 95% confidence interval. This odds ratio was calculated as (presumed cumulative incidence of lymphoedema in intervention group/presumed cumulative incidence of no lymphoedema in intervention group)×(presumed cumulative incidence of no lymphoedema in control group/presumed cumulative incidence of lymphoedema in control group) or (10/90)×(70/30). Conclusion Manual lymph drainage in addition to guidelines and exercise therapy after axillary lymph node dissection for breast cancer is unlikely to have a medium to large effect in reducing the incidence of arm lymphoedema in the short term. Trial registration Netherlands Trial Register No NTR 1055.</abstract><relatedItem type="host"><titleInfo><title>BMJ</title></titleInfo><titleInfo type="abbreviated"><title>BMJ</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0959-8138</identifier><identifier type="eISSN">1468-5833</identifier><identifier type="PublisherID">bmj</identifier><identifier type="PublisherID-hwp">bmj</identifier><identifier type="PublisherID-nlm-ta">BMJ</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>343</number></detail></part></relatedItem><identifier type="istex">6083A6D89AE737BACDB31E790579C486B3899350</identifier><identifier type="DOI">10.1136/bmj.d5326</identifier><identifier type="href">bmj-343-bmj-d5326.pdf</identifier><identifier type="ArticleID">devn830802</identifier><identifier type="local">bmj;343/sep01_1/d5326</identifier><accessCondition type="use and reproduction" contentType="open-access">This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.</accessCondition><recordInfo><recordContentSource>BMJ</recordContentSource><recordOrigin>Devoogdt et al</recordOrigin></recordInfo></mods></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/6083A6D89AE737BACDB31E790579C486B3899350/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/LymphedemaV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002D15 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 002D15 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= LymphedemaV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:6083A6D89AE737BACDB31E790579C486B3899350
|texte= Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial
}}
| This area was generated with Dilib version V0.6.31. |  |