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Spots Global Cancer Trial Database for The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema

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Trial Identification

Brief Title: The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema

Official Title: The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema: A Pragmatic, Randomized, Multicenter Superiority Trial

Study ID: NCT05890677

Study Description

Brief Summary: The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)

Detailed Description: To date, conservative complex physical decongestion therapy (CDT) is the gold standard for BCRL (breast cancer related lymphedema) and includes manual lymphatic drainage, local compression with bandages and garments, physical exercises and meticulous skin care. It is, however, too often ineffective to prevent stage progression in curing BCRL and purely symptomatic. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are two surgical techniques that, in contrast to CDT, are able to actually address the underlying causes and eventually restore the lymphatic drainage. LVA achieves this by creating numerous bypasses between lymphatic vessels and venules allowing the drainage of excessive fluid within the subcutaneous tissues into the venous system, while VLNT usually brings functioning lymph nodes to an area devoid of lymph nodes or with dysfunctional lymph nodes, thus enabling the spontaneous development of new lymphatic pathways. Both techniques have shown very promising results with low complication rates and improved Quality of Life (QoL) for the patients. However, no multicentric randomized controlled trial (RCT) has yet prospectively evaluated the superiority of these surgical techniques over CDT alone, limiting patient's access to most effective treatment available. Requests for cost reimbursement must still be submitted to insurance companies in most countries and are often rejected, thus delaying surgical treatment and resulting in prolonged suffering of affected patients. This is untenable seeing as affected patients suffer from a heavy physical, psychological and financial burden. This pragmatic, randomized, multicenter trial aims to establish a solid scientific basis assessing the superiority of surgical treatment over CDT alone.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Harvard Medical School, Boston, Massachusetts, United States

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States

Universidad de Buenos Aires, Instituto de Oncología Ángel H. Roffo, Buenos Aires, , Argentina

Klinikum Klagenfurt, Klagenfurt, , Austria

University of Ghent, Gent, , Belgium

Hospital Erasto Gaertner, Paraná, Curitiba, Brazil

McGill University, Royal Victoria Hospital, Montreal, , Canada

University of British Columbia, Gordon and Leslie Diamond Health Care Centre, Vancouver, , Canada

Sana Kliniken Düsseldorf, Düsseldorf, , Germany

Uniklinikum Erlangen, Erlangen, , Germany

KEM Evang. Kliniken Essen-Mitte, Essen, , Germany

BG Klinik Frankfurt am Main, Frankfurt, , Germany

Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie, Freiburg im Breisgau, , Germany

Universitätsklinikum Göttingen, Göttingen, , Germany

BG Klinik Ludwigshafen, Ludwigshafen am Rhein, , Germany

Caritas Krankenhaus St. Josef/ Uniklinik Regensburg, Regensburg, , Germany

Papageorgiou Hospital of Thessaloniki, Thessaloníki, , Greece

Plastic and Reconstructive Surgery at Department of Surgical Science, Rome, , Italy

Policlinic Gemelli, Operational Unit of Plastic Surgery, Rome, , Italy

Maastricht University Medical Center, Maastricht, , Netherlands

Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca, Cluj-Napoca, , Romania

Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain

Karolinska Institutet, K1 Molekylär medicin och kirurgi, Stockholm, , Sweden

Department of Plastic and Reconstructive Surgery Uppsala University Hospital, Uppsala, , Sweden

Ospedale Regionale di Lugano, Viganello, Lugano, Switzerland

Kantonsspital Aarau, Aarau, , Switzerland

University Hospital Basel, Basel, , Switzerland

Hôpitaux Universitaires de Genève, Genève, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Kantonsspital Winterthur, Winterthur, , Switzerland

Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie, Zürich, , Switzerland

Contact Details

Name: Elisabeth Kappos, PD Dr. med.

Affiliation: University Hospital, Basel, Switzerland

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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