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Compares treatment options for Lymphedema, Secondary
Official title The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
ClinicalTrials.gov ID: NCT06082349
What this study is testing
- What it's testing
- The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;
- Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;
- Unilateral lymphedema;
- Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);
- Refractory lymphedema that underwent at least three months of conservative treatment;
You likely can't join if
- History of lymphatic reconstruction in the past 10 years;
- Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis;
- Patients with active distant metastases, treated with palliative intent;
- Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted...
- Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;
- Active infection in the lymphedematous extremity;
See the full eligibility criteria
- Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;
- Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;
- Unilateral lymphedema;
- Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);
- Refractory lymphedema that underwent at least three months of conservative treatment;
- Informed consent.
- History of lymphatic reconstruction in the past 10 years;
- Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis;
- Patients with active distant metastases, treated with palliative intent;
- Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible;
- Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;
- Active infection in the lymphedematous extremity;
- Bilateral lymphedema;
- Lymphedema present in genital or breast area only;
- Primary lymphedema;
- Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands; Maastricht, Limburg, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.