NL-OMON43537
Withdrawn
Phase 3
Improving quality of survivorship for breast cancer-related lymphedema by lymphatic microsurgery: A randomized controlled trial - BCRL-LVA study
Medisch Universitair Ziekenhuis Maastricht0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast cancer-related lymphedema (BCRL)
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 60
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Woman over 18 years old
- •\- Treated for early stage breast cancer and underwent an SLNB, ALND or axillary radiotherapy
- •\- Early stage lymphedema of the arm (stage 1 \-\- 2b on ISL classification) with viable lymphatic vessels as determined by nearly infrared imaging
- •\- Excess limb volume \>\=10%
- •\- Followed three months conservative therapy (standard of care) according to best available care, this will be judged by skin therapists in our region
- •\- Primary breast cancer
- •\- Unilateral disease / treatment
Exclusion Criteria
- •\- Male sex
- •\- Stage 3 lymphedema of the arm with evident fat deposition and/or fibrosis
- •\- History of earlier lymph reconstruction efforts
- •\- Recurrent breast cancer
- •\- Distant breast cancer metastases
- •\- Bilateral disease / treatment
- •\- Medical history of cancer
- •\- Primary congenital lymphedema
- •\- Non\-viable lymphatic system as determined by lymphoscintigraphy at inclusion
Outcomes
Primary Outcomes
Not specified
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