The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema (NCT06082349) | Clinical Trial Compass
RecruitingNot Applicable
The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Netherlands110 participantsStarted 2023-12-18
Plain-language summary
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.
A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the Lymph-ICF Score at 12 and 24 months
Timeframe: Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annually during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits).