Improving the Quality of Life of Patients With Breast Cancer-related Lymphedema by Lymphaticovenous Anastomosis (LVA): A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Health-related quality of life: Lymph-ICF questionnaire
Study Overview
Brief Summary
Research question: Is lymphaticovenous anastomosis (LVA) for the treatment of breast cancer-related lymphedema of the arm (BCRL) more effective and cost-effective compared to standard conservative treatment? Hypothesis: LVA improves the health-related quality of life of patients who developed BCRL after breast cancer treatment and is cost-effective compared to conservative treatment. Study design: A multicenter randomised controlled trial (RCT) consisting of two treatment groups: conservative treatment (group A) and LVA (group B). The study is conducted in Maastricht University Medical Center, Radboud University Medical Center, Zuyderland Medical Center and Canisius-Wilhelmina Hospital. Study population: Women over 18 years old who underwent (axillary) treatment for breast cancer presenting with early stage lymphedema of the arm for which they received at least three months conservative treatment Intervention: LVA involves anastomosing lymphatic vessels to small veins to bypass obstructions in the lymphatic system.
Usual care: Complex decongestive therapy (CDT) which includes skin care, manual lymphatic drainage, and compression therapy. Outcome measures: The primary outcome is health-related quality of life after 12 months follow-up measured with the Lymph-ICF questionnaire. Secondary outcomes are (in)direct costs, QALYs, cost-effectiveness ratio, the discontinuation rate of conservative treatment, and excess limb volume. Sample size: A total of 120 patients will be included and randomised in two groups of 60 patients each.
Cost-effectiveness analysis: A trial-based economic evaluation is performed from the societal perspective to determine the cost-effectiveness, expressed in an incremental cost-effectiveness ratio (ICER) (i.e. cost per QALY gained), of LVA compared to CDT. Direct and indirect cost data is collected on the patient-level. The difference in QALYs is assessed with the EQ-5D-5L questionnaire. A Budget Impact Analysis (BIA) will be performed to analyse the financial consequences related to implementing LVA. Time schedule: Patient inclusion will take maximally 21 months. With a follow-up of 24 months, the total study period will be 48 months. The last three months are used for data analysis. Outcome assessment is at inclusion (before randomisation) and 3, 6, 12, 18, and 24 months later.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women over 18 years old
- •Treated for early stage breast cancer and who underwent an sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND) 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 (CDT) prior to inclusion
- •Primary breast cancer
- •Unilateral lymphedema
- •Informed consent
Exclusion Criteria
- •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
Health-related quality of life: Lymph-ICF questionnaire
Time Frame: 12 months
To assess the efficacy of the treatment on disease-related symptoms we will use the "Lymphedema Functioning, Disability and Health" (Lymph-ICF)" questionnaire. This disease-specific questionnaire assesses the impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema. This is a validated questionnaire, based on 5 domains with 29 questions. Each of the 29 questions corresponds to a score between 0-100. The total score on the Lymph-ICF is equal to the sum of the scores on the questions divided by the total number of answered questions. A higher score on the Lymph-ICF indicates more problems with functioning related to arm lymphedema.
Secondary Outcomes
- Cost-effectiveness of LVA compared to complex decongestive therapy(24 months)
- Excess limb volume(24 months)
- Discontinuation rate conservative therapy(24 months)