Comparing lymphaticovenous anastomosis to sham surgery for cancer-related lymphedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) compared to sham surgery in patients with unilateral cancer-related lymphedema affecting either the upper or lower extremity. A total of 110 participants will be randomly assigned to receive either LVA or sham surgery, with follow-up assessments at multiple intervals over two years to measure improvements in Lymph-ICF score, volume reduction, and the need for complex decongestive therapy. The study is conducted across three medical centers in the Netherlands, ensuring a robust evaluation of the intervention's efficacy.

Why it matters

Who can join: the full rules

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).

Where it's running

• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Recruiting
• Maastricht University Medical Center
  Maastricht, Limburg, Netherlands Recruiting
• Erasmus University Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Shan Shan Qiu Shao, MSc, PhD — Maastricht University Medical Center
• Study coordinator: Tanya Wolffenbuttel, MSc
• Email: t.wolffenbuttel@erasmusmc.nl/tanya.wolffenbuttel@mumc.nl
• Phone: +31(0)433877481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.