Improving quality of survivorship for breast cancer-related lymphedema by lymphatic microsurgery: A randomized controlled trial

Phase 3

Withdrawn

Conditions: Breast cancer-related lymphedema (BCRL)
swollen arm
10041641

Registration Number: NL-OMON43537

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Excess limb volume (ELV) after 12 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The cost-effectiveness and quality of life.<br /><br>- Quality of life<br /><br>- The discontinuation rate of conservative treatment after LVA<br /><br>- Arm mobility and strength<br /><br>- Lymph transport measured by lymphoscintigraphy<br /><br>- The difference in ELV after 24 months </p><br>