Trial Title:
The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema
NCT ID:
NCT05890677
Condition:
Lymphedema, Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Conditions: Keywords:
lymphatic surgery
breast cancer related lymphedema
sentinel lymph node biopsy
axillary lymph node dissection
manual lymphatic drainage
conservative complex physical decongestion therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Pragmatic, randomized, international, multicenter superiority trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgical Intervention
Description:
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.
Arm group label:
Group A : Surgical Group
Intervention type:
Procedure
Intervention name:
Conservative Complex Physical Decongestion Therapy
Description:
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.
Arm group label:
Group B: Conservative Complex Physical Decongestion Therapy (control group)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent.
- Patients ≥ 18 years of age.
- Previous diagnosis of breast cancer.
- Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) as defined by
the international society of lymphology (inter-limb difference of >10% in volume or
excess volume between the affected and non-affected limbs present for more than 3
months).
- Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
- Ability to complete the QoL questionnaires.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Harvard Medical School
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Andrea Pusic, Prof. Dr. med.
Phone:
+16 17 732 53 61
Email:
apusic@bwh.harvard.edu
Contact backup:
Last name:
Erin Taylor, Dr. med.
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Justin M. Sacks, Prof. Dr.
Phone:
314-454-4894
Email:
jmsacks@wustl.edu
Facility:
Name:
Universidad de Buenos Aires, Instituto de Oncología Ángel H. Roffo
Address:
City:
Buenos Aires
Zip:
C1417
Country:
Argentina
Status:
Not yet recruiting
Contact:
Last name:
Eduardo Gonzalez, Dr. med.
Phone:
+54 11 15 5180 4224
Email:
egonzalez57@hotmail.com
Contact backup:
Email:
edugonzalez57@gmail.com
Facility:
Name:
Klinikum Klagenfurt
Address:
City:
Klagenfurt
Zip:
9020
Country:
Austria
Status:
Not yet recruiting
Contact:
Last name:
Madeleine Mischitz, Dr.
Phone:
0043 463 538 22970
Email:
Madeleine.Mischitz@kabeg.at
Contact backup:
Last name:
Matthias Rab, Dr.
Facility:
Name:
University of Ghent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Phillip Blondeel, Prof. Dr.
Email:
Phillip.Blondeel@ugent.be
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Paraná
Zip:
80730-001
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Anne Karoline Groth, Dr. med.
Phone:
+55(41)32183300
Email:
annegroth@gmail.com
Facility:
Name:
McGill University, Royal Victoria Hospital
Address:
City:
Montreal
Zip:
QC H4A 3J1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Josh Vorstenbosch, MD PhD FRCSC
Phone:
+1(514)934-1934 x 35194
Email:
joshua.vorstenbosch@mcgill.ca
Contact backup:
Last name:
Anna Towers, Dr.
Facility:
Name:
University of British Columbia, Gordon and Leslie Diamond Health Care Centre
Address:
City:
Vancouver
Zip:
BC V5Z 1M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Kathryn V. Isaac, Asst. Prof. Dr.
Phone:
+1 604-336-9488
Email:
kathryn.isaac@ubc.ca
Facility:
Name:
Sana Kliniken Düsseldorf
Address:
City:
Düsseldorf
Zip:
40593
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Katrin Seidenstücker, Dr.
Phone:
+49 211 2800 1990
Email:
katrin.seidenstuecker@sana.de
Facility:
Name:
Uniklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Raymund Horch, Prof. Dr.
Email:
Raymund.Horch@uk-erlangen.de
Facility:
Name:
KEM Evang. Kliniken Essen-Mitte
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Björn Behr, Prof. Dr. med.
Phone:
+49 234 302 7152
Email:
transchirurgie-zentrum@kem-med.com
Contact backup:
Phone:
+49 201 174 29006
Email:
bjorn.behr@rub.de
Facility:
Name:
BG Klinik Frankfurt am Main
Address:
City:
Frankfurt
Zip:
60389
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Christoph Hirche, Prof. Dr. med.
Phone:
+49 69 475 23 23
Email:
ulrich.kneser@bgu-ludwigshafen.de
Facility:
Name:
Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie
Address:
City:
Freiburg im Breisgau
Zip:
79106
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Steffen Eisenhardt, Prof. Dr. med.
Phone:
+49 761 270 28170
Email:
steffen.eisenhardt@uniklinik-freiburg.de
Contact backup:
Email:
bianca.kremer@uniklinik-freiburg.de
Facility:
Name:
Universitätsklinikum Göttingen
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Gunther Felmerer, Prof. Dr. Med.
Phone:
0551 / 39 - 65422
Email:
plastische.chirurgie@med.uni-goettingen.de
Facility:
Name:
BG Klinik Ludwigshafen
Address:
City:
Ludwigshafen am Rhein
Zip:
67071
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Ulrich Kneser, Prof. Dr. med.
Phone:
+49 621 681 023 28
Email:
ulrich.kneser@bgu-ludwigshafen.de
Facility:
Name:
Caritas Krankenhaus St. Josef/ Uniklinik Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Lukas Prantl, Prof. Dr. med.
Phone:
+49 941 944 6763
Email:
Lukas.Prantl@klinik.uni-regensburg.de
Contact backup:
Last name:
Norbert Heine, Dr. med.
Facility:
Name:
Papageorgiou Hospital of Thessaloniki
Address:
City:
Thessaloníki
Zip:
55133
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Efterpi Demiri, Prof. Dr. med.
Phone:
+30 231 332 38 38
Email:
demirie@auth.gr
Contact backup:
Last name:
Dimitrios Dionysiou, Dr. med.
Facility:
Name:
Plastic and Reconstructive Surgery at Department of Surgical Science
Address:
City:
Rome
Zip:
00133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Benedetto Longo, Dr. med.
Phone:
+39 6 44291148
Email:
benedetto.longo@uniroma2.it
Contact backup:
Email:
info@benedettolongo.com
Facility:
Name:
Policlinic Gemelli, Operational Unit of Plastic Surgery
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Visconti, Dr. med.
Phone:
+39 06 30151
Email:
giuseppe.visconti@policlinicogemelli.it
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6202
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Shao Shan Qiu, Dr.
Phone:
+31(0)43-3877481
Email:
shanshan.qiushao@mumc.nl
Facility:
Name:
Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Contact:
Last name:
Maximilian Vlad Muntean, Dr. med.
Phone:
+40 730085422
Email:
maximilian.muntean@gmail.com
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Gemma Pons, Dr.
Phone:
+34 935565693
Email:
GPonsP@santpau.cat
Facility:
Name:
Karolinska Institutet, K1 Molekylär medicin och kirurgi
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Not yet recruiting
Contact:
Last name:
Martin Halle, Dr. med.
Phone:
+46 8 123 708 46
Email:
martin.halle@ki.se
Facility:
Name:
Department of Plastic and Reconstructive Surgery Uppsala University Hospital
Address:
City:
Uppsala
Zip:
751 85
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Maria Mani, Dr. med.
Email:
Maria.Mani@surgsci.uu.se
Facility:
Name:
Ospedale Regionale di Lugano
Address:
City:
Viganello
Zip:
6962
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Yves Harder, Prof. Dr. med.
Phone:
+41 91 811 75 47
Email:
yves.harder@eoc.ch
Facility:
Name:
Kantonsspital Aarau
Address:
City:
Aarau
Zip:
5001
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Jan Plock, Prof. Dr. med.
Phone:
+41 62 838 47 31
Email:
plastischechirurgie@ksa.ch
Facility:
Name:
University Hospital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Elisabeth Kappos, Prof. Dr.
Phone:
+41 61 328 62 54
Email:
elisabeth.kappos@usb.ch
Investigator:
Last name:
Elisabeth Kappos, Prof. Dr.
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Universitaires de Genève
Address:
City:
Genève
Zip:
1205
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Daniel Kalbermatten, Prof. Dr. med.
Phone:
+41 22 372 80 12
Email:
daniel.kalbermatten@hcuge.ch
Facility:
Name:
Centre Hospitalier Universitaire Vaudois
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Pietro di Summa, PD Dr. med.
Phone:
+41 21 314 25 25
Email:
pietro.di-summa@chuv.ch
Facility:
Name:
Kantonsspital Winterthur
Address:
City:
Winterthur
Zip:
8401
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Florian Jung, Dr. med.
Phone:
+41 52 266 24 08
Email:
Florian.Jung@ksw.ch
Facility:
Name:
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Nicole Lindenblatt, Prof. Dr. med.
Phone:
+41 44 255 11 11
Email:
nicole.lindenblatt@usz.ch
Start date:
July 14, 2023
Completion date:
June 2036
Lead sponsor:
Agency:
University Hospital, Basel, Switzerland
Agency class:
Other
Collaborator:
Agency:
Swiss National Science Foundation
Agency class:
Other
Collaborator:
Agency:
Rising Tide Foundation
Agency class:
Other
Collaborator:
Agency:
Krebsforschung Schweiz, Bern, Switzerland
Agency class:
Other
Source:
University Hospital, Basel, Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05890677
