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

NCT ID: NCT05890677

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2036-06-30

Brief Summary

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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

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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.

Conditions

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Lymphedema, Breast Cancer

Keywords

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lymphatic surgery breast cancer related lymphedema sentinel lymph node biopsy axillary lymph node dissection manual lymphatic drainage conservative complex physical decongestion therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic, randomized, international, multicenter superiority trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A : Surgical Group

According to the pragmatic study design, neither the diagnostic workup nor the surgery will be standardized in order to offer surgeons considerable leeway on how to perform lymphatic surgery, which resembles the flexibility in usual care. The key aspects of the preoperative workup and the surgery including the number of LVAs (Lymphovenous Anastomosis), harvesting of lymph nodes ("donor site"), time of surgery, and practical details will be registered.

Group Type EXPERIMENTAL

Surgical Intervention

Intervention Type PROCEDURE

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 single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.

Group B: Conservative Complex Physical Decongestion Therapy (control group)

CDT (Conservative Complex Physical Decongestion Therapy) will be performed as in usual care, following the pragmatic study design. The key aspects like frequency of lymphatic drainage, time when lymphatic drainage is performed and time and class of compressive garments are used will be documented. CDT incorporates two stages of treatment. The first treatment phase (intensive phase) entails skincare, MLD (manual lymphatic drainage), exercises aimed at improvement of mobility/range of motion in the shoulder, elbow or wrist joints, and compression therapy through bandaging. Most patients undergo this phase shortly after the diagnosis of LE. CDT in the second phase (maintenance phase) aims to maintain the achieved limb volume/ circumference reduction through compression with therapeutic elastic compression garment for the arm. Skincare, mobility exercises and MLD is continued in this phase if needed

Group Type ACTIVE_COMPARATOR

Conservative Complex Physical Decongestion Therapy

Intervention Type PROCEDURE

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 CDT will be done at the discretion of the treating physiotherapist.

Interventions

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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 single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.

Intervention Type PROCEDURE

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 CDT will be done at the discretion of the treating physiotherapist.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Rising Tide Foundation

OTHER

Sponsor Role collaborator

Krebsforschung Schweiz, Bern, Switzerland

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Kappos, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Harvard Medical School

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Site Status RECRUITING

Mayo Clinic

Rochester, New York, United States

Site Status NOT_YET_RECRUITING

Krankenhaus Göttlicher Heiland GmbH

Vienna, , Austria

Site Status NOT_YET_RECRUITING

Brussels University Hospital

Brussels, Jette, Belgium

Site Status NOT_YET_RECRUITING

University of Ghent

Ghent, , Belgium

Site Status RECRUITING

Hospital Erasto Gaertner

Paraná, Curitiba, Brazil

Site Status NOT_YET_RECRUITING

McGill University, Royal Victoria Hospital

Montreal, , Canada

Site Status RECRUITING

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

Vancouver, , Canada

Site Status RECRUITING

BG Universitätsklinikum Bergmannsheil Bochum

Bochum, , Germany

Site Status RECRUITING

Sana Kliniken Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Uniklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

KEM Evang. Kliniken Essen-Mitte

Essen, , Germany

Site Status RECRUITING

BG Klinik Frankfurt am Main

Frankfurt, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie

Freiburg im Breisgau, , Germany

Site Status RECRUITING

BG Klinik Ludwigshafen

Ludwigshafen am Rhein, , Germany

Site Status RECRUITING

Klinikum Nürnberg

Nuremberg, , Germany

Site Status RECRUITING

Caritas Krankenhaus St. Josef/ Uniklinik Regensburg

Regensburg, , Germany

Site Status RECRUITING

Papageorgiou Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Rambam Health Clinic, ISR

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Policlinico Tor Vergata: Fondazione PTV

Rome, , Italy

Site Status NOT_YET_RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Rome, , Italy

Site Status RECRUITING

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status RECRUITING

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

Cluj-Napoca, , Romania

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Karolinska Institutet, K1 Molekylär medicin och kirurgi

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Department of Plastic and Reconstructive Surgery Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

Kantonsspital Aarau

Aarau, , Switzerland

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status RECRUITING

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status RECRUITING

Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie

Zurich, , Switzerland

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

Countries

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Argentina United States Austria Belgium Brazil Canada Germany Greece Israel Italy Netherlands Romania Spain Sweden Switzerland Taiwan

Central Contacts

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Elisabeth Kappos, Prof. Dr.

Role: CONTACT

Phone: +41 61 328 62 54

Email: [email protected]

Facility Contacts

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Siba Haykal, MD, PhD.

Role: primary

Andrea Pusic, Prof. Dr. med.

Role: primary

Erin Taylor, Dr. med.

Role: backup

Justin M. Sacks, Prof. Dr.

Role: primary

Vahe Fahrradyan, MD

Role: primary

Tina Deutinger, MD, PhD

Role: primary

Mustapha/Alexandru Hamdi/Nistor, MD

Role: primary

Phillip Blondeel, Prof. Dr.

Role: primary

Anne Karoline Groth, Dr. med.

Role: primary

Josh Vorstenbosch, MD PhD FRCSC

Role: primary

Anna Towers, Dr.

Role: backup

Kathryn V. Isaac, Asst. Prof. Dr.

Role: primary

Christoph Wallner, PD Dr. med., M.Sc., MHBA

Role: primary

Katrin Seidenstücker, Dr.

Role: primary

Raymund Horch, Prof. Dr.

Role: primary

Björn Behr, Prof. Dr. med.

Role: primary

Role: backup

Christoph Hirche, Prof. Dr. med.

Role: primary

Steffen Eisenhardt, Prof. Dr. med.

Role: primary

Role: backup

Ulrich Kneser, Prof. Dr. med.

Role: primary

Denis Ehrl, MD

Role: primary

Lukas Prantl, Prof. Dr. med.

Role: primary

Norbert Heine, Dr. med.

Role: backup

Efterpi Demiri, Prof. Dr. med.

Role: primary

Dimitrios Dionysiou, Dr. med.

Role: backup

Assaf Zeltzer

Role: primary

Benedetto Longo, Dr. med.

Role: primary

Role: backup

Giuseppe Visconti, Dr. med.

Role: primary

Shao Shan Qiu, Dr.

Role: primary

Maximilian Vlad Muntean, Dr. med.

Role: primary

Gemma Pons, Dr.

Role: primary

Martin Halle, Dr. med.

Role: primary

Maria Mani, Dr. med.

Role: primary

Jan Plock, Prof. Dr. med.

Role: primary

Elisabeth Kappos, Prof. Dr.

Role: primary

Daniel Kalbermatten, Prof. Dr. med.

Role: primary

Pietro di Summa, PD Dr. med.

Role: primary

Florian Jung, Dr. med.

Role: primary

Nicole Lindenblatt, Prof. Dr. med.

Role: primary

Johnson Chia-Shen Yang, MD

Role: primary

References

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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, Taylor EM, Mani M, Jung FJ, di Summa PG, Demiri E, Dionyssiou D, Groth AK, Heine N, Vorstenborsch J, Isaac KV, Qiu SS, Engels PE, Serre A, Eberhardt AL, Ebner S, Schwenkglenks M, Stoel Y, Leo C, Horch RE, Blondeel P, Behr B, Kneser U, Prantl L, Boll DT, Granziera C, Hemkens L, Lindenblatt N, Haug M, Schaefer DJ, Hirche C, Pusic AL, Seidenstuecker K, Harder Y, Weber W. The LYMPH trial: comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema - study protocol of a pragmatic randomised international multicentre superiority trial. BMJ Open. 2025 Feb 17;15(2):e090662. doi: 10.1136/bmjopen-2024-090662.

Reference Type DERIVED
PMID: 39961719 (View on PubMed)

Other Identifiers

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2023-00733; mu21kappos

Identifier Type: -

Identifier Source: org_study_id

NCT07045831

Identifier Type: -

Identifier Source: nct_alias