The primary objective of this randomized controlled trial is to study the effectiveness of lymphaticovenous anastomosis (LVA) compared to complex decongestive therapy (CDT) in terms of health-related quality of life (HRQoL). Secondary objectives are…
ID
Source
Brief title
Condition
- Spleen, lymphatic and reticuloendothelial system disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is health-related quality of life after 12 months follow-up
measured with the Lymph-ICF questionnaire.
Secondary outcome
Secondary outcomes are (in)direct costs, QALYs, cost-effectiveness ratio, the
discontinuation rate of conservative treatment, and excess limb volume.
Background summary
Early breast cancer detection and concomitant advancements in treatment options
have not only resulted in an increase of breast cancer survival rates, but also
in disease-related morbidities. In other words, an increasing number of women
are living with the side effects of breast cancer treatment, making the quality
of survivorship an increasingly important goal. Breast cancer-related
lymphedema (BCRL) is one of the most underestimated complications of breast
cancer treatment, of which the onset can occur at any time after primary cancer
treatment with a reported incidence of 30% to 40% after axillary lymph node
dissection (ALND) and 7% after sentinel lymph node biopsy (SLNB). Although the
axillary treatment regimens are changing with a focus on less aggressive
axillary treatment in order to reduce morbidity without compromising survival,
BCRL will still remain a relevant problem in the future.
Study objective
The primary objective of this randomized controlled trial is to study the
effectiveness of lymphaticovenous anastomosis (LVA) compared to complex
decongestive therapy (CDT) in terms of health-related quality of life (HRQoL).
Secondary objectives are to compare LVA to CDT in terms of cost-effectiveness,
the discontinuation rate of compression stockings, and the change in excess arm
volume.
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.
Intervention
Patients will be randomized into two groups. One group will receive conservate
therapy and the second group will undergo lymphatic microsurgery by
lymphaticovenous anastomosis (LVA).
Study burden and risks
The patients randomized to the microsurgical group are subject to minor
surgical complications (infection, bleeding, failure of lymphatic system
restoration), which is a one-time risk during the course of this study. The
patients will have a total of 6 control visits: at inclusion, after 3, 6, 12,
18, and 24 months. During a visit, patients will undergo a physical
examination, the volume of the arms will be measured and two questionnaires
(Lymph-ICF and EQ-5D-5L) have to be filled out. A visit takes approximately 60
minutes.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02790021 |
| CCMO | NL67059.068.18 |