Efficacy and safety of Wuling San for treatment of breast-cancer-related upper extremity lymphoedema: study protocol for a pilot trial
Identifieur interne : 001128 ( Main/Merge ); précédent : 001127; suivant : 001129Efficacy and safety of Wuling San for treatment of breast-cancer-related upper extremity lymphoedema: study protocol for a pilot trial
Auteurs : Huiru Zhu [République populaire de Chine] ; Zheng Peng [République populaire de Chine] ; Meiyu Dai [République populaire de Chine] ; Yan Zou [République populaire de Chine] ; Fengxian Qin [République populaire de Chine] ; Jifei Chen [République populaire de Chine] ; Liuying Song [République populaire de Chine] ; Baoyu He [République populaire de Chine] ; Xiaolan Lv [République populaire de Chine] ; Shengming Dai [République populaire de Chine]Source :
- BMJ Open [ 2044-6055 ] ; 2016.
Abstract
Breast-cancer-related upper extremity lymphoedema (BCUL), a common complication of mastectomy, can cause physical discomfort, psychological distress, cosmetic defects, functional disability and chronic recurrent erysipelas in the affected arm(s). It is a challenge to physicians involved in the management of these patients. Wuling San, a classic prescription in Traditional Chinese Medicine used in treating oedema for thousands of years, is reported by many Chinese journals to perform well in BCUL. Therefore, the aim of this study is to verify its efficacy and evaluate its safety using rigorous methodological designs in patients with BCUL.
To verify the efficacy and assess the safety of Wuling San over a placebo, this double-blind, randomised, placebo-controlled, multicentre trial will be carried out in three hospitals. A total of 200 eligible patients with BCUL will be randomly allocated, in a ratio of 1:1, to either the experimental medicine group or the placebo group. The primary outcome measure will be the proportion of absolute reduced limb volume, as measured by perometry. The second outcome measure will be the number of participants with adverse events. The assessment will be carried out at the following time points: before enrolment (baseline) and 2, 4, 6 and 8 weeks after treatment.
This trial will be conducted in accordance with the Declaration of Helsinki and supervised by the institutional review board of the Fourth Affiliated Hospital of Guangxi Medical University (approval number PJK2016088). All patients will receive information about the trial in verbal and written forms and will give informed consent before enrolment. This trial will help to demonstrate whether Wuling San is effective in the treatment of patients with BCUL. The results will be published in peer-reviewed journals or disseminated through conference presentations.
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DOI: 10.1136/bmjopen-2016-012515
PubMed: 27986736
PubMed Central: 5168680
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type="wicri:Area/Main/Merge">001128</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Efficacy and safety of Wuling San for treatment of breast-cancer-related upper extremity lymphoedema: study protocol for a pilot trial</title><author><name sortKey="Zhu, Huiru" sort="Zhu, Huiru" uniqKey="Zhu H" first="Huiru" last="Zhu">Huiru Zhu</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Galactophore</addr-line>,<institution>The Third Affiliated Hospital of Guangxi University of Chinese Medicine</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Peng, Zheng" sort="Peng, Zheng" uniqKey="Peng Z" first="Zheng" last="Peng">Zheng Peng</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dai, Meiyu" sort="Dai, Meiyu" uniqKey="Dai M" first="Meiyu" last="Dai">Meiyu Dai</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Zou, Yan" sort="Zou, Yan" uniqKey="Zou Y" first="Yan" last="Zou">Yan Zou</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Qin, Fengxian" sort="Qin, Fengxian" uniqKey="Qin F" first="Fengxian" last="Qin">Fengxian Qin</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Chen, Jifei" sort="Chen, Jifei" uniqKey="Chen J" first="Jifei" last="Chen">Jifei Chen</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Song, Liuying" sort="Song, Liuying" uniqKey="Song L" first="Liuying" last="Song">Liuying Song</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="He, Baoyu" sort="He, Baoyu" uniqKey="He B" first="Baoyu" last="He">Baoyu He</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lv, Xiaolan" sort="Lv, Xiaolan" uniqKey="Lv X" first="Xiaolan" last="Lv">Xiaolan Lv</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>Liuzhou Maternal and Child Health Care Hospital</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dai, Shengming" sort="Dai, Shengming" uniqKey="Dai S" first="Shengming" last="Dai">Shengming Dai</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Clinical Laboratory</addr-line>,<institution>The Fourth Affiliated Hospital of Guangxi Medical University</institution>,<addr-line>Liuzhou, Guangxi</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMJ Open</title><idno type="eISSN">2044-6055</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>Breast-cancer-related upper extremity lymphoedema (BCUL), a common complication of mastectomy, can cause physical discomfort, psychological distress, cosmetic defects, functional disability and chronic recurrent erysipelas in the affected arm(s). It is a challenge to physicians involved in the management of these patients. Wuling San, a classic prescription in Traditional Chinese Medicine used in treating oedema for thousands of years, is reported by many Chinese journals to perform well in BCUL. Therefore, the aim of this study is to verify its efficacy and evaluate its safety using rigorous methodological designs in patients with BCUL.</p></sec><sec><title>Methods and analysis</title><p>To verify the efficacy and assess the safety of Wuling San over a placebo, this double-blind, randomised, placebo-controlled, multicentre trial will be carried out in three hospitals. A total of 200 eligible patients with BCUL will be randomly allocated, in a ratio of 1:1, to either the experimental medicine group or the placebo group. The primary outcome measure will be the proportion of absolute reduced limb volume, as measured by perometry. The second outcome measure will be the number of participants with adverse events. The assessment will be carried out at the following time points: before enrolment (baseline) and 2, 4, 6 and 8 weeks after treatment.</p></sec><sec><title>Ethics and dissemination</title><p>This trial will be conducted in accordance with the Declaration of Helsinki and supervised by the institutional review board of the Fourth Affiliated Hospital of Guangxi Medical University (approval number PJK2016088). All patients will receive information about the trial in verbal and written forms and will give informed consent before enrolment. This trial will help to demonstrate whether Wuling San is effective in the treatment of patients with BCUL. The results will be published in peer-reviewed journals or disseminated through conference presentations.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02726477?term=wuling+san&rank=1">NCT02726477</ext-link>; Pre-results.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Maclellan, Ra" uniqKey="Maclellan R">RA Maclellan</name></author><author><name sortKey="Greene, Ak" uniqKey="Greene A">AK Greene</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Coriddi, M" uniqKey="Coriddi M">M Coriddi</name></author><author><name sortKey="Khansa, I" uniqKey="Khansa I">I Khansa</name></author><author><name sortKey="Stephens, J" uniqKey="Stephens J">J Stephens</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Paskett, Ed" uniqKey="Paskett E">ED Paskett</name></author><author><name 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Yoon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhao, Yy" uniqKey="Zhao Y">YY Zhao</name></author><author><name sortKey="Lei, P" uniqKey="Lei P">P Lei</name></author><author><name sortKey="Chen, Dq" uniqKey="Chen D">DQ Chen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hsu, Pc" uniqKey="Hsu P">PC Hsu</name></author><author><name sortKey="Tsai, Yt" uniqKey="Tsai Y">YT Tsai</name></author><author><name sortKey="Lai, Jn" uniqKey="Lai J">JN Lai</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zhang, G" uniqKey="Zhang G">G Zhang</name></author><author><name sortKey="Zeng, X" uniqKey="Zeng X">X Zeng</name></author><author><name sortKey="Han, L" uniqKey="Han L">L Han</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Feng, Yl" uniqKey="Feng Y">YL Feng</name></author><author><name sortKey="Chen, H" uniqKey="Chen H">H Chen</name></author><author><name sortKey="Tian, T" uniqKey="Tian T">T Tian</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Fan, Lc" uniqKey="Fan L">LC Fan</name></author><author><name sortKey="Yin, Cp" uniqKey="Yin C">CP Yin</name></author><author><name sortKey="Liu, Jh" uniqKey="Liu J">JH Liu</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ozbayer, C" uniqKey="Ozbayer C">C Ozbayer</name></author><author><name sortKey="Kurt, H" uniqKey="Kurt H">H Kurt</name></author><author><name sortKey="Ozdemir, Z" uniqKey="Ozdemir Z">Z Ozdemir</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Guo, L" uniqKey="Guo L">L Guo</name></author><author><name sortKey="Sun, Yl" uniqKey="Sun Y">YL Sun</name></author><author><name sortKey="Wang, Ah" uniqKey="Wang A">AH Wang</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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