Lymphedema of Upper Limb Clinical Trial
Official title:
Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | March 1, 2029 |
Est. primary completion date | March 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy; - Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity; - Unilateral lymphedema; - Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III); - Refractory lymphedema that underwent at least three months of conservative treatment; - Informed consent. Exclusion Criteria: - History of lymphatic reconstruction in the past 10 years; - Late-stage lymphedema of the extremity (ISL classification = II lymphedema) with evident fat deposition and/or fibrosis; - Patients with active distant metastases, treated with palliative intent; - Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible; - Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system; - Active infection in the lymphedematous extremity; - Bilateral lymphedema; - Lymphedema present in genital or breast area only; - Primary lymphedema; - Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Netherlands | Erasmus University Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Erasmus Medical Center, Radboud University Medical Center |
Netherlands,
Kleeven A, Jonis YMJ, Tielemans H, van Kuijk S, Kimman M, van der Hulst R, Vasilic D, Hummelink S, Qiu SS. The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial. BMJ Open. 2024 Apr 15;14(4):e086226. doi: 10.1136/bmjopen-2024-086226. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Lymph-ICF Score at 12 and 24 months | The Dutch version of the 'Lymphedema Functioning, Disability, and Health" (Lymph-ICF) questionnaire is used. There are two versions of the Lymph-ICF; one for the upper extremity and one for the lower extremity. The questionnaires assess the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items across 5 domains. Each item is scored on a VAS, ranging from 0 to 100. | Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Change from baseline in excess limb volume | The excess limb volume will be measured with BioImpedance Spectroscopy (BIS). With a bioimpedance device, the volume of the extremities can be measured together with the fluid in different compartments of the extremities. | Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Change from baseline in extremity circumference measured by the Upper and Lower Extremity Lymphedema (UEL and LEL) indices | The extremity circumference will be measured using measuring tape according to the fixed measuring points of the UEL- and LEL-indices. The UEL- and LEL-indices are corrected for BMI. | Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Change from baseline in the use of conservative treatment | Discontinuation of conservative treatment, being complex decongestive therapy, will be assessed with a patient diary to record the frequency of treatments received (i.e. skin therapy visits, number of compression garments, etc.). | Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Postoperative complications | All postoperative complications for both treatment groups will be recorded to monitor safety. SAEs will be directly reported to the sponsor. | Baseline, 3, 6, 12, 18 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Patency of the LVA | The patency of the LVAs will be measured with ICG lymphography | 12 and 24 months post-operatively and afterwards annualy during the extended follow-up, lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). | |
Secondary | Patient costs, QALYs, and incremental cost-effectiveness | Patients costs are registered by the patient in the patient diary. The QALY will be calculated using the EQ-5D-5L questionnaire. The EQ-5D is a questionnaire responsive to changes in health in cancer-patients after the conclusion of treatment. | , lasting up to the start of the first analysis (maximally 3 years extra or 3 additional visits). |
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