NCT06082349 The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
| NCT ID | NCT06082349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Lymphedema, Secondary |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-12-18 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Tanya Wolffenbuttel, MSc
✉ t.wolffenbuttel@erasmusmc.nl/tanya.wolffenbuttel@mumc.nl📞 +31(0)433877481
Shan Shan Qiu Shao, MSc, PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT06082349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphedema, Secondary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082349 currently recruiting?
Yes, NCT06082349 is actively recruiting participants. Contact the research team at t.wolffenbuttel@erasmusmc.nl/tanya.wolffenbuttel@mumc.nl for enrollment information.
Where is the NCT06082349 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Maastricht, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT06082349 clinical trial?
NCT06082349 is sponsored by Maastricht University Medical Center. The principal investigator is Shan Shan Qiu Shao, MSc, PhD at Maastricht University Medical Center. The trial plans to enroll 110 participants.