To assess the effectivity of LVA on arm volume in comparison to standard therapy after 12 months.
ID
Source
Brief title
Condition
- Spleen, lymphatic and reticuloendothelial system disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Excess limb volume (ELV) after 12 months
Secondary outcome
- The cost-effectiveness and quality of life.
- Quality of life
- The discontinuation rate of conservative treatment after LVA
- Arm mobility and strength
- Lymph transport measured by lymphoscintigraphy
- The difference in ELV after 24 months
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. This study aims to
improve the quality of breast cancer survivorship by reducing/eliminating one
of the most debilitating upper-body morbidities related to breast cancer
treatment: chronic lymphedema.
Study objective
To assess the effectivity of LVA on arm volume in comparison to standard
therapy after 12 months.
Study design
A multicenter, randomized controlled trial carried out in the Maastricht
University Medical Center, VieCuri Medical Center and Zuyderland Medical
Center.
Intervention
In this RCT patients are randomized over two arms: the first group will
continue standard of care conservative lymphedema therapy, while the second
group will undergo lymphatic microsurgery known as lympho-venular anastomoses
(LVA) by a plastic surgeon.
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.
Patients are exposed to a radiation dose of 0.3 mSv divided over 3
lymphoscintigraphies during the two year study period. After randomization the
follow-up moments will be at 1, 3, 6, 12 and 24 months. A follow-up moment
includes an interview and a medical examination. During this examination, the
upper limbs will be assessed for sensory, motor, strength and mobility changes.
Furthermore, we will measure the volume of the treated and untreated side using
the water displacement method and circumference measurement. Subjects will also
be asked at certain time points to fill in five questionnaires: *Lymphedema
Functioning, Disability and Health (Lymph-ICF)*, *European Organization for
Research and Treatment of Cancer QLQ-C30 *, *European Organization for Research
and Treatment of Cancer QLQ-BR23*, *EQ-5D-5L* and the *Disabilities of the arm,
shoulder and hand (DASH)* questionnaire. Lastly, a lymphoscintigraphy will be
made at inclusion and after 12 months at the MUMC+.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
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 | NL56477.068.16 |