Multi-center rater-blinded study of early intervention with the Hand Incubator for breast cancer-related lymphedema (the BEAT-EDEMA trial): Proposal of a research protocol.
Identifieur interne : 000214 ( PubMed/Checkpoint ); précédent : 000213; suivant : 000215Multi-center rater-blinded study of early intervention with the Hand Incubator for breast cancer-related lymphedema (the BEAT-EDEMA trial): Proposal of a research protocol.
Auteurs : Hisao Ishii ; Katsuyuki Iwatsuki ; Masahiro Tatebe ; Hitoshi Hirata ; Toyone Kikumori ; Nobuyuki Tsunoda ; Ikuo Hyodo ; Tomoko Ogawa ; Naoki UnnoSource :
- Nagoya journal of medical science [ 0027-7622 ] ; 2017.
Abstract
Postoperative lymphedema is considered irreversible once it has developed, and significantly lowers the patient's quality of life. However, lymphatic function has recently been clarified, and it is possible that lymphedema can be cured if early treatment is started. This two-arm randomized clinical trial (UMIN000026124) will prospectively evaluate 24 patients with early-stage breast cancer-related lymphedema at the Nagoya University Hospital and Aichi Cancer Center Hospital. The eligibility criteria will be patients who are diagnosed with stage 0-1 breast cancer-related lymphedema, as defined by the International Society of Lymphology, within 12 weeks after breast cancer surgery. The diagnosis of lymphedema will be confirmed using a bioimpedance spectroscopy device (L-Dex®). Participants will be randomized 1:1 into the intervention and control groups. The physicians and patients will be aware of their group assignment, although treatment efficacy will be evaluated by raters who are blinded to the group assignments. The intervention group will complete grasping exercises in the Hand Incubator device for 4 weeks. The primary outcome will be the change in the affected upper limb's volume after the intervention, as measured using the water displacement method. This study may help establish a standard treatment for postoperative lymphedema.
DOI: 10.18999/nagjms.79.2.221
PubMed: 28626257
Affiliations:
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Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Tatebe, Masahiro" sort="Tatebe, Masahiro" uniqKey="Tatebe M" first="Masahiro" last="Tatebe">Masahiro Tatebe</name><affiliation><nlm:affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Hirata, Hitoshi" sort="Hirata, Hitoshi" uniqKey="Hirata H" first="Hitoshi" last="Hirata">Hitoshi Hirata</name><affiliation><nlm:affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Kikumori, Toyone" sort="Kikumori, Toyone" uniqKey="Kikumori T" first="Toyone" last="Kikumori">Toyone Kikumori</name><affiliation><nlm:affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Tsunoda, Nobuyuki" sort="Tsunoda, Nobuyuki" uniqKey="Tsunoda N" first="Nobuyuki" last="Tsunoda">Nobuyuki Tsunoda</name><affiliation><nlm:affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Hyodo, Ikuo" sort="Hyodo, Ikuo" uniqKey="Hyodo I" first="Ikuo" last="Hyodo">Ikuo Hyodo</name><affiliation><nlm:affiliation>Department of Plastic and Reconstructive Surgery, Aichi Cancer Center Hospital.</nlm:affiliation><wicri:noCountry code="subField">Aichi Cancer Center Hospital</wicri:noCountry></affiliation></author><author><name sortKey="Ogawa, Tomoko" sort="Ogawa, 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sortKey="Iwatsuki, Katsuyuki" sort="Iwatsuki, Katsuyuki" uniqKey="Iwatsuki K" first="Katsuyuki" last="Iwatsuki">Katsuyuki Iwatsuki</name><affiliation><nlm:affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Tatebe, Masahiro" sort="Tatebe, Masahiro" uniqKey="Tatebe M" first="Masahiro" last="Tatebe">Masahiro Tatebe</name><affiliation><nlm:affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Hirata, Hitoshi" sort="Hirata, Hitoshi" uniqKey="Hirata H" first="Hitoshi" last="Hirata">Hitoshi Hirata</name><affiliation><nlm:affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Kikumori, Toyone" sort="Kikumori, Toyone" uniqKey="Kikumori T" first="Toyone" last="Kikumori">Toyone Kikumori</name><affiliation><nlm:affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Tsunoda, Nobuyuki" sort="Tsunoda, Nobuyuki" uniqKey="Tsunoda N" first="Nobuyuki" last="Tsunoda">Nobuyuki Tsunoda</name><affiliation><nlm:affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Nagoya University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Hyodo, Ikuo" sort="Hyodo, Ikuo" uniqKey="Hyodo I" first="Ikuo" last="Hyodo">Ikuo Hyodo</name><affiliation><nlm:affiliation>Department of Plastic and Reconstructive Surgery, Aichi Cancer Center Hospital.</nlm:affiliation><wicri:noCountry code="subField">Aichi Cancer Center Hospital</wicri:noCountry></affiliation></author><author><name sortKey="Ogawa, Tomoko" sort="Ogawa, Tomoko" uniqKey="Ogawa T" first="Tomoko" last="Ogawa">Tomoko Ogawa</name><affiliation><nlm:affiliation>Department of Breast Surgery, Mie University Graduate School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Mie University Graduate School of Medicine</wicri:noCountry></affiliation></author><author><name sortKey="Unno, Naoki" sort="Unno, Naoki" uniqKey="Unno N" first="Naoki" last="Unno">Naoki Unno</name><affiliation><nlm:affiliation>Division of Vascular Surgery, Second Department of Surgery, Hamamatsu University School of Medicine.</nlm:affiliation><wicri:noCountry code="subField">Hamamatsu University School of Medicine</wicri:noCountry></affiliation></author></analytic><series><title level="j">Nagoya journal of medical science</title><idno type="ISSN">0027-7622</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">Postoperative lymphedema is considered irreversible once it has developed, and significantly lowers the patient's quality of life. However, lymphatic function has recently been clarified, and it is possible that lymphedema can be cured if early treatment is started. This two-arm randomized clinical trial (UMIN000026124) will prospectively evaluate 24 patients with early-stage breast cancer-related lymphedema at the Nagoya University Hospital and Aichi Cancer Center Hospital. The eligibility criteria will be patients who are diagnosed with stage 0-1 breast cancer-related lymphedema, as defined by the International Society of Lymphology, within 12 weeks after breast cancer surgery. The diagnosis of lymphedema will be confirmed using a bioimpedance spectroscopy device (L-Dex®). Participants will be randomized 1:1 into the intervention and control groups. The physicians and patients will be aware of their group assignment, although treatment efficacy will be evaluated by raters who are blinded to the group assignments. The intervention group will complete grasping exercises in the Hand Incubator device for 4 weeks. The primary outcome will be the change in the affected upper limb's volume after the intervention, as measured using the water displacement method. This study may help establish a standard treatment for postoperative lymphedema.</div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">28626257</PMID><DateCreated><Year>2017</Year><Month>06</Month><Day>19</Day></DateCreated><DateRevised><Year>2017</Year><Month>07</Month><Day>14</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0027-7622</ISSN><JournalIssue CitedMedium="Print"><Volume>79</Volume><Issue>2</Issue><PubDate><Year>2017</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Nagoya journal of medical science</Title><ISOAbbreviation>Nagoya J Med Sci</ISOAbbreviation></Journal><ArticleTitle>Multi-center rater-blinded study of early intervention with the Hand Incubator for breast cancer-related lymphedema (the BEAT-EDEMA trial): Proposal of a research protocol.</ArticleTitle><Pagination><MedlinePgn>221-227</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.18999/nagjms.79.2.221</ELocationID><Abstract><AbstractText>Postoperative lymphedema is considered irreversible once it has developed, and significantly lowers the patient's quality of life. However, lymphatic function has recently been clarified, and it is possible that lymphedema can be cured if early treatment is started. This two-arm randomized clinical trial (UMIN000026124) will prospectively evaluate 24 patients with early-stage breast cancer-related lymphedema at the Nagoya University Hospital and Aichi Cancer Center Hospital. The eligibility criteria will be patients who are diagnosed with stage 0-1 breast cancer-related lymphedema, as defined by the International Society of Lymphology, within 12 weeks after breast cancer surgery. The diagnosis of lymphedema will be confirmed using a bioimpedance spectroscopy device (L-Dex®). Participants will be randomized 1:1 into the intervention and control groups. The physicians and patients will be aware of their group assignment, although treatment efficacy will be evaluated by raters who are blinded to the group assignments. The intervention group will complete grasping exercises in the Hand Incubator device for 4 weeks. The primary outcome will be the change in the affected upper limb's volume after the intervention, as measured using the water displacement method. This study may help establish a standard treatment for postoperative lymphedema.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ishii</LastName><ForeName>Hisao</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Iwatsuki</LastName><ForeName>Katsuyuki</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tatebe</LastName><ForeName>Masahiro</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hirata</LastName><ForeName>Hitoshi</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Hand Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kikumori</LastName><ForeName>Toyone</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tsunoda</LastName><ForeName>Nobuyuki</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hyodo</LastName><ForeName>Ikuo</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Department of Plastic and Reconstructive Surgery, Aichi Cancer Center Hospital.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ogawa</LastName><ForeName>Tomoko</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Breast Surgery, Mie University Graduate School of Medicine.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Unno</LastName><ForeName>Naoki</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Division of Vascular Surgery, Second Department of Surgery, Hamamatsu University School of Medicine.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Japan</Country><MedlineTA>Nagoya J Med Sci</MedlineTA><NlmUniqueID>0412011</NlmUniqueID><ISSNLinking>0027-7622</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Breast J. 2006 Nov-Dec;12(6):536-43</RefSource><PMID Version="1">17238983</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer. 2008 Jun 15;112(12):2809-19</RefSource><PMID Version="1">18428212</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 2013 Mar;46(1):1-11</RefSource><PMID Version="1">23930436</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Pers Med. 2015 May 20;5(2):153-64</RefSource><PMID Version="1">26011383</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Breast Cancer Res Treat. 1996;38(2):169-76</RefSource><PMID Version="1">8861835</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Vasc Surg. 2010 Oct;52(4):946-52</RefSource><PMID Version="1">20619581</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Oncol. 2013 May;14(6):500-15</RefSource><PMID Version="1">23540561</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 1998 Jun;31(2):43-55</RefSource><PMID Version="1">9664268</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):775-82</RefSource><PMID Version="1">17416770</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 2010 Sep;43(3):118-27</RefSource><PMID Version="1">21226414</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cochrane Database Syst Rev. 2015 Feb 13;(2):CD009765</RefSource><PMID Version="1">25677413</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Physiol. 2007 Aug 15;583(Pt 1):271-85</RefSource><PMID Version="1">17569739</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 2005 Dec;38(4):167-80</RefSource><PMID Version="1">16515225</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Pers Med. 2014 Aug 18;4(3):424-47</RefSource><PMID Version="1">25563360</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Oncologist. 2013;18(4):350-2</RefSource><PMID Version="1">23576481</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Semin Cell Dev Biol. 2015 Feb;38:55-66</RefSource><PMID Version="1">25617600</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Phys Med Rehabil. 2016 Feb;97(2):302-315.e13</RefSource><PMID Version="1">26440777</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lymphology. 2010 Jun;43(2):85-94</RefSource><PMID Version="1">20848996</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">breast cancer</Keyword><Keyword MajorTopicYN="N">exercise therapy</Keyword><Keyword MajorTopicYN="N">lymphedema</Keyword><Keyword MajorTopicYN="N">randomized controlled trial</Keyword><Keyword MajorTopicYN="N">rater-blinded study</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>6</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>6</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>6</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28626257</ArticleId><ArticleId IdType="doi">10.18999/nagjms.79.2.221</ArticleId><ArticleId IdType="pmc">PMC5472547</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list></list><tree><noCountry><name sortKey="Hirata, Hitoshi" sort="Hirata, Hitoshi" uniqKey="Hirata H" first="Hitoshi" last="Hirata">Hitoshi Hirata</name><name sortKey="Hyodo, Ikuo" sort="Hyodo, Ikuo" uniqKey="Hyodo I" first="Ikuo" last="Hyodo">Ikuo Hyodo</name><name sortKey="Ishii, Hisao" sort="Ishii, Hisao" uniqKey="Ishii H" first="Hisao" last="Ishii">Hisao Ishii</name><name sortKey="Iwatsuki, Katsuyuki" sort="Iwatsuki, Katsuyuki" uniqKey="Iwatsuki K" first="Katsuyuki" last="Iwatsuki">Katsuyuki Iwatsuki</name><name sortKey="Kikumori, Toyone" sort="Kikumori, Toyone" uniqKey="Kikumori T" first="Toyone" last="Kikumori">Toyone Kikumori</name><name sortKey="Ogawa, Tomoko" sort="Ogawa, Tomoko" uniqKey="Ogawa T" first="Tomoko" last="Ogawa">Tomoko Ogawa</name><name sortKey="Tatebe, Masahiro" sort="Tatebe, Masahiro" uniqKey="Tatebe M" first="Masahiro" last="Tatebe">Masahiro Tatebe</name><name sortKey="Tsunoda, Nobuyuki" sort="Tsunoda, Nobuyuki" uniqKey="Tsunoda N" first="Nobuyuki" last="Tsunoda">Nobuyuki Tsunoda</name><name sortKey="Unno, Naoki" sort="Unno, Naoki" uniqKey="Unno N" first="Naoki" last="Unno">Naoki Unno</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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