Improving the quality of life of patients with breast cancer-related lymphedema by lymphaticovenous anastomosis (LVA): A randomized controlled trial

Phase 3

Recruiting

• Conditions: Breast cancer-related lymphedema; swollen arm; 10041641

• Registration Number: NL-OMON55376
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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
- Informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is health-related quality of life after 12 months follow-up<br /><br>measured with the Lymph-ICF questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are (in)direct costs, QALYs, cost-effectiveness ratio, the<br /><br>discontinuation rate of conservative treatment, and excess limb volume.</p><br>