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/Curation ); 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 [Belgique] ; Marie-Rose Christiaens ; Inge Geraerts [Belgique] ; Steven Truijen ; Ann Smeets ; Karin Leunen ; Patrick Neven ; Marijke Van Kampen [Belgique]Source :
- 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.
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DOI: 10.1136/bmj.d5326
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Marie-Rose Christiaens<affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation><wicri:noCountry code="subField">Leuven</wicri:noCountry></affiliation><affiliation><mods:affiliation>Department of Health Care, Artesis University College of Antwerp, Antwerp</mods:affiliation><wicri:noCountry code="subField">Antwerp</wicri:noCountry></affiliation><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation><wicri:noCountry code="subField">Leuven</wicri:noCountry></affiliation><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation><wicri:noCountry code="subField">Leuven</wicri:noCountry></affiliation><affiliation><mods:affiliation>Multidisciplinary Breast Centre, University Hospitals Leuven and Faculty of Medicine, Katholieke Universiteit Leuven, Leuven</mods:affiliation><wicri:noCountry code="subField">Leuven</wicri:noCountry></affiliation>Le document en format XML
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code="subField">Leuven</wicri:noCountry></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><wicri:noCountry code="subField">Leuven</wicri:noCountry></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 wicri:level="1"><mods:affiliation>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven, Belgium</mods:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven and Department of Physiotherapy, University Hospitals Leuven, Leuven</wicri:regionArea></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></record>Pour manipuler ce document sous Unix (Dilib)
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