The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema

Официальное название

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

Обзор

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)

Подробное описание

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.

Вмешательства

• Процедура Surgical Intervention
  LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and singl
• Процедура Conservative Complex Physical Decongestion Therapy
  Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but

Первичные конечные точки

• Change in Quality of Life Questionnaire (Lymph-ICF-UL) [Срок оценки: two time assessment at baseline and 15 month after randomization]

Вторичные конечные точки (11)

• Change in Quality of Life Questionnaire (Lymph-ICF-UL) [Срок оценки: 13 time assessment up to 10 years after randomization]
• Change in Quality of Life Questionnaire (LYMPH-Q) [Срок оценки: 15 time assessment up to 10 years after randomization]
• Change in Quality of Life Questionnaire (EuroQol EQ-5D-5L) [Срок оценки: 15 time assessment up to 10 years after randomization]
• Change in Pain score (visual analog scale) [Срок оценки: 7 time assessment up to 2 years after randomization]
• Assessment of (serious) adverse events [Срок оценки: 7 time assessment up to 2 years after randomization]
• Assessment of surgical complications [Срок оценки: 7 time assessment up to 2 years after randomization]
• Assessment of lymphangitic events (erysipelas) [Срок оценки: 7 time assessment up to 2 years after randomization]
• Assessment of arm volume [Срок оценки: 15 time assessment up to 10 years after randomization]
• Assessment of the frequency of lymphatic drainage [Срок оценки: 15 time assessment up to 10 years after randomization]
• Assessment of the burden on patients [Срок оценки: 9 time assessment up to 10 years after randomization]
• Assessment of the economics (for Switzerland) [Срок оценки: 9 time assessment up to 10 years after randomization]

Критерии участия

Критерии включения

• Written informed consent.
• Patients ≥ 18 years of age.
• Former diagnosis of breast cancer.
• Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
• Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
• Ability to complete the QoL questionnaires.
• Willingness to undergo surgery.

Критерии исключения

• No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
• Primary congenital Lymphedema or non-BCRL.
• Previous surgical BCRL treatment on the side intended for intervention.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 9 центров

• BG Universitätsklinikum Bergmannsheil Bochum — Bochum
• Sana Kliniken Düsseldorf — Düsseldorf
• Uniklinikum Erlangen — Erlangen
• KEM Evang. Kliniken Essen-Mitte — Essen
• BG Klinik Frankfurt am Main — Frankfurt
• Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie — Freiburg im Breisgau
• BG Klinik Ludwigshafen — Ludwigshafen am Rhein
• Klinikum Nürnberg — Nuremberg
• … и ещё 1 центр

Швейцария · 6 центров

• University Hospital Basel — Basel
• Centre Hospitalier Universitaire Vaudois — Lausanne
• Kantonsspital Aarau — Aarau
• Hôpitaux Universitaires de Genève — Geneva
• Kantonsspital Winterthur — Winterthur
• Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie — Zurich

США · 4 центра

• Yale School of Medicine — New Haven
• Harvard Medical School — Boston
• Washington University School of Medicine in St. Louis — St Louis
• Mayo Clinic — Rochester

Австрия · 2 центра

• University Clinics St.Pölten — Sankt Pölten
• Krankenhaus Göttlicher Heiland GmbH — Vienna

Бельгия · 2 центра

• Brussels University Hospital — Brussels
• University of Ghent — Ghent

Канада · 2 центра

• McGill University, Royal Victoria Hospital — Montreal
• University of British Columbia, Gordon and Leslie Diamond Health Care Centre — Vancouver

Италия · 2 центра

• Policlinico Tor Vergata: Fondazione PTV — Rome
• Policlinico Universitario Fondazione Agostino Gemelli — Rome

Швеция · 2 центра

• Karolinska Institutet, K1 Molekylär medicin och kirurgi — Stockholm
• Department of Plastic and Reconstructive Surgery Uppsala University Hospital — Uppsala

Бразилия · 1 центр

• Hospital Erasto Gaertner — Paraná

Греция · 1 центр

• Papageorgiou Hospital of Thessaloniki — Thessaloniki

Израиль · 1 центр

• Rambam Health Clinic, ISR — Haifa

Нидерланды · 1 центр

• Maastricht University Medical Center — Maastricht

Румыния · 1 центр

• Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca — Cluj-Napoca

Испания · 1 центр

• Hospital de la Santa Creu i Sant Pau — Barcelona

Тайвань · 1 центр

• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City

Публикации

• Kappos EA, Haas Y, Schulz A, Peters F, Savanthrapadian S, Stoffel J, Katapodi MC, Mucklow R, Kaiser B, Haumer A, Etter S, Cattaneo M, Staub D, Ribi K, Shaw J, Handschin TM, Eisenhardt S, Visconti G, Franceschini G, Scardina L, Longo B, Vetter M, Zaman K, Plock JA, Scaglioni M, Gonzalez EG, Quildrian SD, Felmerer G, Mehrara BJ, Ayala JM, Pons G, Kalbermatten DF, Sacks JM, Halle M, Muntean MV, Taylo PMID 39961719

Идентификаторы

NCT: NCT05890677 · 2023-00733; mu21kappos

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗