Comparing lymphaticovenous anastomosis to sham surgery for cancer-related lymphedema
Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
This study is testing if a new surgery for cancer-related lymphedema can help people feel better compared to a fake surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Nijmegen, Gelderland and 2 other locations) |
| Trial ID | NCT06082349 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have been treated for cancer and have developed early-stage unilateral lymphedema after lymph node treatment or radiotherapy.
Not a fit: Patients with late-stage lymphedema, active distant metastases, or those currently undergoing primary cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from cancer-related lymphedema.
How similar studies have performed: While previous studies on LVA have been small and of varying quality, this trial represents a novel large-scale approach to assess its efficacy.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Nijmegen, Gelderland and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.