Lymphedema, Breast Cancer Clinical Trial
— LYMPHOfficial title:
The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema: A Pragmatic, Randomized, Multicenter Superiority Trial
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)
Status | Recruiting |
Enrollment | 280 |
Est. completion date | December 2035 |
Est. primary completion date | June 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Written informed consent. - Patients = 18 years of age with prior treatment of breast cancer. - At least one of the following prior breast cancer treatments: sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), radiotherapy (RT) of chest wall or axilla or breast cancer surgery. - Clinical diagnosis of chronic BCRL as defined by the ISL (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 CDT. - 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 LE or non-breast cancer-related LE. - Need for immediate LE surgery according to clinical judgement by a specialist due to far progressed LE stage. |
Country | Name | City | State |
---|---|---|---|
Argentina | Universidad de Buenos Aires, Instituto de Oncología Ángel H. Roffo | Buenos Aires | |
Austria | Klinikum Klagenfurt | Klagenfurt | |
Belgium | University of Ghent | Gent | |
Brazil | Hospital Erasto Gaertner | Paraná | Curitiba |
Canada | McGill University, Royal Victoria Hospital | Montreal | |
Canada | University of British Columbia, Gordon and Leslie Diamond Health Care Centre | Vancouver | |
Germany | 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 | |
Greece | Papageorgiou Hospital of Thessaloniki | Thessaloníki | |
Italy | Plastic and Reconstructive Surgery at Department of Surgical Science | Rome | |
Italy | Policlinic Gemelli, Operational Unit of Plastic Surgery | Rome | |
Netherlands | Maastricht University Medical Center | Maastricht | |
Romania | Institute of Oncology ''Prof. Dr. Ion Chiricu?a'' of Cluj-Napoca | Cluj-Napoca | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Sweden | Karolinska Institutet, K1 Molekylär medicin och kirurgi | Stockholm | |
Sweden | Department of Plastic and Reconstructive Surgery Uppsala University Hospital | Uppsala | |
Switzerland | Kantonsspital Aarau | Aarau | |
Switzerland | University Hospital Basel | Basel | |
Switzerland | Hôpitaux Universitaires de Genève | Genève | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | Ospedale Regionale di Lugano | Viganello | Lugano |
Switzerland | Kantonsspital Winterthur | Winterthur | |
Switzerland | Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie | Zürich | |
United States | Harvard Medical School | Boston | Massachusetts |
United States | Washington University School of Medicine in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Krebsforschung Schweiz, Bern, Switzerland, Rising Tide Foundation, Swiss National Science Foundation |
United States, Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, Italy, Netherlands, Romania, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quality of Life Questionnaire (Lymph-ICF-UL) | The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy. | two time assessment at baseline and 15 month after randomization | |
Secondary | Change in Quality of Life Questionnaire (Lymph-ICF-UL) | The LYMPH-ICF-UL-Questionnaire (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema) is a widely used, rigorously developed, and validated patient-reported outcome (PRO) instrument for chronic breast cancer-related lymphedema. It assesses the impairments in function, activity limitations and participation restrictions of patients with upper limb lymphedema (LE). Consisting of 29 items (questions) across five different domains, each item is scored on a VAS (visual analog scale) ranging from 0 to 10. The total score on the LYMPH-ICF is equal to the sum of the item scores divided by the total number of answered items. A higher score on the Lymph-ICF indicates a greater impact on the functioning in daily life related to upper limb LE. This questionnaire helps determine if lymphatic surgery improves quality of life and patient satisfaction compared to conservative therapy. | 13 time assessment up to 10 years after randomization | |
Secondary | Change in Quality of Life Questionnaire (LYMPH-Q) | The Lymph-Q Upper Extremity Module is a new PROM (patient-reported outcome measure) developed to assess patient reported outcomes of BCRL in a concept-driven approach. The complete questionnaire contains 68 questions covering the patient-relevant topics Health-related quality of life (arm appearance, arm function, arm symptoms, psychological), experience of care (information), and treatment (arm sleeve).
The questionnaire is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy. |
15 time assessment up to 10 years after randomization | |
Secondary | Change in Quality of Life Questionnaire (EuroQol EQ-5D-5L) | The 5-level EQ-5D version (EQ-5D-5L) consists of the EQ-5D descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions (5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems) resulting in a 1-digit number that expresses the level for that dimension. The digits for each dimension can be combined into a 5-digit number that describes the patient's health state.
The questionnaire is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy. |
15 time assessment up to 10 years after randomization | |
Secondary | Change in Pain score (visual analog scale) | The pain score consists of a VAS (visual analog scale) ranging from 0 (i.e. no pain) to 10 (i.e. worst pain). The VAS was published by the Yale University.
It is used to determine whether lymphatic surgery provides better quality of life and patient satisfaction compared to conservative therapy. |
7 time assessment up to 2 years after randomization | |
Secondary | Assessment of (serious) adverse events | Safety is assessed via a rigorous and detailed examination of (serious) adverse events. | 7 time assessment up to 2 years after randomization | |
Secondary | Assessment of surgical complications | For the surgery group only, safety is assessed via a rigorous and detailed examination of complications of surgery. Grading is according to the modified classification of Clavien-Dindo, categorizing them into five levels ranging from minor deviations to life-threatening events.
The assessment will cover both surgical stages in case of two-staged lymphedema (LE) surgery. |
7 time assessment up to 2 years after randomization | |
Secondary | Assessment of lymphangitic events (erysipelas) | The frequency of lymphangitic events (erysipelas) is closely monitored. Lymphangitic events are defined as skin infections at the lymphedema site(s) which can be treated with oral or intravenous antibiotics. The type of antibiotic given, the application form, type of hospital stay and necessity of a surgery will be assessed. | 7 time assessment up to 2 years after randomization | |
Secondary | Assessment of arm volume | Arm volume is determined by measuring the circumference of each arm at 10 cm intervals from the wrist to the axilla. The volume of each arm segment is calculated using a truncated cone model, and percentage edema volume is derived from the volume difference between the affected and unaffected arms. Both relative (relative to the unaffected arm) and absolute (volume reduction of the affected arm at the next measurement) volume change are calculated, corrected for BMI and differences between dominant and non-dominant arms. | 15 time assessment up to 10 years after randomization | |
Secondary | Assessment of the frequency of lymphatic drainage | The frequency of lymphatic drainage before the start of the study and between the study's follow-up visits is assessed. | 15 time assessment up to 10 years after randomization | |
Secondary | Assessment of the burden on patients | To assess the burden on patients, information regarding the total number of operative procedures, length of hospital stays, number of outpatient visits, and absence from work within two years after randomization and during the extended follow-up is collected. | 9 time assessment up to 10 years after randomization | |
Secondary | Assessment of the economics (for Switzerland) | To perform an economic evaluation, information regarding the condition-related medical resource use, healthcare costs, indirect costs, productivity losses, and incremental cost-effectiveness (quality-adjusted life-years) is collected.
The information is based on the responses to the EQ-5D-5L questionnaire, the questions asked under burden on patients, and on other medical resource information recorded in the trial primarily for clinical purposes, at the respective visits. In addition, direct extraction of breast cancer-related lymphedema-related in- and outpatient costs, and corresponding key resource use parameters, are collected from the hospital administration systems of the participating Swiss sites, once at the 2 year follow-up visit . |
9 time assessment up to 10 years after randomization |
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