NL-OMON55376
Recruiting
Phase 3
Improving the quality of life of patients with breast cancer-related lymphedema by lymphaticovenous anastomosis (LVA): A randomized controlled trial - LYMPH-trial
Medisch Universitair Ziekenhuis Maastricht0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Women over 18 years old
- •\- Treated for early stage breast cancer and who underwent a sentinel lymph node
- •biopsy, axillary lymph node dissection or axillary radiotherapy
- •\- Early stage lymphedema of the arm (ISL classification stage I/IIa; pitting
- •edema without fibrosis) with viable lymphatic vessels as determined by
- •indocyanin green (ICG\-) lymphography
- •\- Already received at least three months of complex decongestive therapy
- •(currently in the maintenance phase) prior to inclusion
- •\- Primary breast cancer
- •\- Unilateral lymphedema
Exclusion Criteria
- •\- Male sex
- •\- Late stage lymphedema of the arm (ISL classification IIb/III lymphedema) with
- •evident fat deposition and/or fibrosis
- •\- History of earlier lymph reconstruction efforts
- •\- Recurrent breast cancer
- •\- Distant breast cancer metastases
- •\- Bilateral lymphedema
- •\- Primary congenital lymphedema
- •\- Non\-viable lymphatic system as determined by ICG lymphography
Outcomes
Primary Outcomes
Not specified
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