The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Oct 9, 2023

Keywords

ClinConnect Summary

The N-LVA Study is a clinical trial that aims to find out if a surgical procedure called lymphaticovenous anastomosis (LVA) is more effective than a fake surgery (sham surgery) for treating cancer-related lymphedema, which is swelling that can occur after cancer treatment. This study will include 110 participants who will be randomly divided into two groups: one will receive the LVA procedure, and the other will undergo sham surgery. The goal is to see if those who have LVA experience better improvement in their swelling and overall quality of life.

To be eligible for this trial, participants should have been treated for cancer and have early-stage lymphedema affecting only one arm or leg. They must also have tried conservative treatments like compression therapy for at least three months without significant improvement. Participants can expect to be part of a well-monitored study, which could help improve treatment options for lymphedema in the future. It’s important to note that individuals with certain conditions, like advanced lymphedema or active infections, will not be eligible to participate.

Gender

ALL

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).