The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial

Elisabeth A Kappos, Yvonne Haas, Alexandra Schulz, Florian Peters, Shakuntala Savanthrapadian, Julia Stoffel, Maria Katapodi, Rosine Mucklow, Benedict Kaiser, Alexander Haumer, Stephanie Etter, Marco Cattaneo, Daniel Staub, Karin Ribi, Jane Shaw, Tristan M Handschin, Steffen Eisenhardt, Giuseppe Visconti, Gianluca Franceschini, Lorenzo Scardina, Benedetto Longo, Marcus Vetter, Khalil Zaman, Jan A Plock, Mario Scaglioni, Eduardo G Gonzalez, Sergio D Quildrian, Gunther Felmerer, Babak J Mehrara, Jaume Masia, Gemma Pons, Daniel F Kalbermatten, Justin M Sacks, Martin Halle, Maximillian V Muntean, Erin M Taylor, Maria Mani, Florian J Jung, Pietro G di Summa, Efterpi Demiri, Dimitris Dionyssiou, Anne K Groth, Norbert Heine, Joshua Vorstenborsch, Kathryn V Isaac, Shan S Qiu, Patricia E Engels, Axelle Serre, Anna-Lena Eberhardt, Sonja Ebner, Matthias Schwenkglenks, Yvette Stoel, Cornelia Leo, Raymund E Horch, Phillip Blondeel, Bjoern Behr, Ulrich Kneser, Lukas Prantl, Daniel T Boll, Cristina Granziera, Lars G Hemkens, Nicole Lindenblatt, Martin Haug, Dirk J Schaefer, Christoph Hirche, Andrea L Pusic, Katrin Seidenstuecker, Yves Harder, Walter P Weber
{"title":"The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial","authors":"Elisabeth A Kappos, Yvonne Haas, Alexandra Schulz, Florian Peters, Shakuntala Savanthrapadian, Julia Stoffel, Maria Katapodi, Rosine Mucklow, Benedict Kaiser, Alexander Haumer, Stephanie Etter, Marco Cattaneo, Daniel Staub, Karin Ribi, Jane Shaw, Tristan M Handschin, Steffen Eisenhardt, Giuseppe Visconti, Gianluca Franceschini, Lorenzo Scardina, Benedetto Longo, Marcus Vetter, Khalil Zaman, Jan A Plock, Mario Scaglioni, Eduardo G Gonzalez, Sergio D Quildrian, Gunther Felmerer, Babak J Mehrara, Jaume Masia, Gemma Pons, Daniel F Kalbermatten, Justin M Sacks, Martin Halle, Maximillian V Muntean, Erin M Taylor, Maria Mani, Florian J Jung, Pietro G di Summa, Efterpi Demiri, Dimitris Dionyssiou, Anne K Groth, Norbert Heine, Joshua Vorstenborsch, Kathryn V Isaac, Shan S Qiu, Patricia E Engels, Axelle Serre, Anna-Lena Eberhardt, Sonja Ebner, Matthias Schwenkglenks, Yvette Stoel, Cornelia Leo, Raymund E Horch, Phillip Blondeel, Bjoern Behr, Ulrich Kneser, Lukas Prantl, Daniel T Boll, Cristina Granziera, Lars G Hemkens, Nicole Lindenblatt, Martin Haug, Dirk J Schaefer, Christoph Hirche, Andrea L Pusic, Katrin Seidenstuecker, Yves Harder, Walter P Weber","doi":"10.1101/2024.02.13.24302744","DOIUrl":null,"url":null,"abstract":"Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis: The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome lymphedema-specific QoL, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination: This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee Ethikkommission Nordwest- und Zentralschweiz (2023-00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration: The trial is registered at https://clinicaltrials.gov (ID: NCT05890677) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de. The date of first registration was 23.05.2023. Strengths and limitations of this study:\n-This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL.\n-The pragmatic design will reflect clinical practice, thereby directly providing applicable results.\n-A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. -Patient advocates were intensely involved throughout the trial design.\n-To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting access of the patients to available treatment options.\n-The assessment of treatment quality (both conservative and surgical) at various sites is challenging due to potential variations resulting from the pragmatic design, which may influence the outcomes of the study.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"medRxiv - Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2024.02.13.24302744","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis: The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome lymphedema-specific QoL, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination: This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee Ethikkommission Nordwest- und Zentralschweiz (2023-00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration: The trial is registered at https://clinicaltrials.gov (ID: NCT05890677) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de. The date of first registration was 23.05.2023. Strengths and limitations of this study: -This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL. -The pragmatic design will reflect clinical practice, thereby directly providing applicable results. -A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. -Patient advocates were intensely involved throughout the trial design. -To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting access of the patients to available treatment options. -The assessment of treatment quality (both conservative and surgical) at various sites is challenging due to potential variations resulting from the pragmatic design, which may influence the outcomes of the study.
LYMPH试验--比较乳腺癌相关慢性淋巴水肿的显微手术与保守治疗:务实的国际多中心随机优越性试验的研究方案
导言:多达五分之一的乳腺癌幸存者会出现慢性乳腺癌相关淋巴水肿(BCRL)。迄今为止,复合物理去充血疗法(CDT)是治疗的金标准。然而,这种疗法主要是对症治疗,通常无法有效预防乳腺癌相关淋巴水肿的发展。淋巴管吻合术(LVA)和血管化淋巴结转移术(VLNT)是旨在恢复淋巴引流的显微外科技术。这项国际随机试验旨在评估显微外科干预加 CDT 与单用 CDT 治疗 BCRL 的优势。方法与分析:将在全球范围内评估 LVA 和/或 VLNT 与 CDT(可与吸脂术相结合)相结合与单纯 CDT 相比的效果。BCRL 患者将被随机分配接受手术或保守治疗。该试验的主要终点是患者报告的淋巴水肿特异性生活质量(QoL)结果,将在随机分配后15个月进行评估。次要终点是进一步的患者报告结果(PROs)、手臂体积测量、经济评估和不同时间点的影像学检查。长期随访将在随机分组后进行,直至 10 年。将在全球 20 多个地点招募 280 名患者。伦理和传播:本研究将遵照《赫尔辛基宣言》和 ICH-GCP E6 指南进行。伦理委员会 Nordwest- und Zentralschweiz(2023-00733,2023 年 5 月 22 日)已获得伦理批准。所有参与研究的机构都将获得当地政府的伦理批准。无论结果如何,研究结果都将发表在同行评审的医学期刊上。数据集类型、规模和内容的详细元数据将与完整的研究方案和病例报告表一起,按照 FAIR 原则在公共资料库中公布。试验注册:该试验已在 https://clinicaltrials.gov(ID:NCT05890677)和瑞士国家临床试验门户网站(SNCTP,BASEC project-ID:2023-00733)https://kofam.ch/de。首次注册日期为 2023 年 5 月 23 日。本研究的优势和局限性:-这是一项务实、随机、国际性、多中心、优越性试验,有可能对慢性 BCRL 患者的临床治疗实践产生影响-务实的设计将反映临床实践,从而直接提供适用的结果-将进行长达 10 年的全面长期随访,以评估和分析长期结果。-迄今为止,还没有一项多中心 RCT 比较过可能结合吸脂术的显微外科技术(LVA 和 VLNT)与单纯 CDT,从而限制了患者获得现有治疗方案的机会。由于务实的设计可能导致差异,从而影响研究结果,因此对不同部位的治疗质量(包括保守治疗和手术治疗)进行评估具有挑战性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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