Lymphedema Clinical Trials

Find Lymphedema Clinical Trials Near You

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

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Yale School of Medicine
NOT_YET_RECRUITING
New Haven
Massachusetts
Harvard Medical School
NOT_YET_RECRUITING
Boston
Missouri
Washington University School of Medicine in St. Louis
RECRUITING
St Louis
New York
Mayo Clinic
NOT_YET_RECRUITING
Rochester
Other Locations
Austria
Krankenhaus Göttlicher Heiland GmbH
NOT_YET_RECRUITING
Vienna
Belgium
Brussels University Hospital
NOT_YET_RECRUITING
Brussels
University of Ghent
RECRUITING
Ghent
Brazil
Hospital Erasto Gaertner
NOT_YET_RECRUITING
Paraná
Canada
McGill University, Royal Victoria Hospital
RECRUITING
Montreal
University of British Columbia, Gordon and Leslie Diamond Health Care Centre
RECRUITING
Vancouver
Germany
BG Universitätsklinikum Bergmannsheil Bochum
RECRUITING
Bochum
Sana Kliniken Düsseldorf
RECRUITING
Düsseldorf
Uniklinikum Erlangen
RECRUITING
Erlangen
KEM Evang. Kliniken Essen-Mitte
RECRUITING
Essen
BG Klinik Frankfurt am Main
RECRUITING
Frankfurt
Universitätsklinikum Freiburg, Klinik für Plastische und Handchirurgie
RECRUITING
Freiburg Im Breisgau
BG Klinik Ludwigshafen
RECRUITING
Ludwigshafen Am Rhein
Klinikum Nürnberg
RECRUITING
Nuremberg
Caritas Krankenhaus St. Josef/ Uniklinik Regensburg
RECRUITING
Regensburg
Greece
Papageorgiou Hospital of Thessaloniki
RECRUITING
Thessaloniki
Israel
Rambam Health Clinic, ISR
NOT_YET_RECRUITING
Haifa
Italy
Policlinico Tor Vergata: Fondazione PTV
NOT_YET_RECRUITING
Rome
Policlinico Universitario Fondazione Agostino Gemelli
RECRUITING
Rome
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Romania
Institute of Oncology ''Prof. Dr. Ion Chiricuță'' of Cluj-Napoca
RECRUITING
Cluj-napoca
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Sweden
Karolinska Institutet, K1 Molekylär medicin och kirurgi
NOT_YET_RECRUITING
Stockholm
Department of Plastic and Reconstructive Surgery Uppsala University Hospital
RECRUITING
Uppsala
Switzerland
Kantonsspital Aarau
RECRUITING
Aarau
University Hospital Basel
RECRUITING
Basel
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Kantonsspital Winterthur
RECRUITING
Winterthur
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie
RECRUITING
Zurich
Taiwan
Kaohsiung Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Contact Information
Primary
Elisabeth Kappos, Prof. Dr.
elisabeth.kappos@usb.ch
+41 61 328 62 54
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2036-06
Participants
Target number of participants: 280
Treatments
Experimental: 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.
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Collaborators: Rising Tide Foundation, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov