The LYMPH trial: comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema - study protocol of a pragmatic randomised international multicentre superiority trial.
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Kappos Elisabeth A, Haas Yvonne, Schulz Alexandra, Peters Florian, Savanthrapadian Shakuntala, Stoffel Julia, Katapodi Maria C, Mucklow Rosine, Kaiser Benedict, Haumer Alexander, Etter Stephanie, Cattaneo Marco, Staub Daniel, Ribi Karin, Shaw Jane, Handschin Tristan M, Eisenhardt Steffen, Visconti Giuseppe, Franceschini Gianluca, Scardina Lorenzo, Longo Benedetto, Vetter Marcus, Zaman Khalil, Plock Jan A, Scaglioni Mario, Gonzalez Eduardo G, Quildrian Sergio D, Felmerer Gunther, Mehrara Babak J, Ayala Jaume Masia, Pons Gemma, Kalbermatten Daniel F, Sacks Justin M, Halle Martin, Muntean Maximillian V, Taylor Erin M, Mani Maria, Jung Florian J, di Summa Pietro G, Demiri Efterpi, Dionyssiou Dimitris, Groth Anne K, Heine Norbert, Vorstenborsch Joshua, Isaac Kathryn V, Qiu Shan Shan, Engels Patricia E, Serre Axelle, Eberhardt Anna-Lena, Ebner Sonja, Schwenkglenks Matthias, Stoel Yvette, Leo Cornelia, Horch Raymund E, Blondeel Phillip, Behr Bjoern, Kneser Ulrich, Prantl Lukas, Boll Daniel T, Granziera Cristina, Hemkens Lars, Lindenblatt Nicole, Haug Martin, Schaefer Dirk J, Hirche Christoph, Pusic Andrea L, Seidenstuecker Katrin, Harder Yves, Weber Walter
Аннотация
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. Patients with BCRL will be randomly allocated to either surgical or conservative therapy. The primary end point of this trial is the patient-reported quality of life (QoL) outcome 'lymphoedema-specific QoL', which will be assessed 15 months after randomisation. Secondary end points are further patient-reported outcomes (PROs), arm volume measurements, economic evaluations and imaging at different time points. A long-term follow-up will be conducted up to 10 years after randomisation. 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 International Council for Harmonisation-Good Clinical Practice (ICH-GCP) E6 guideline. Ethical approval has been obtained by the lead ethics committee 'Ethikkommission Nordwest- und Zentralschweiz' (2023-00733, 22 May 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's 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 Findability, Accessibility, Interoperability and Reuse principles.
TRIAL REGISTRATION NUMBER: NCT05890677.