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Microsurgical Treatment of Breast Cancer-related Lymphedema by Lymphaticovenous Anastomosis

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ClinicalTrials.gov Identifier: NCT02790021
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Lymphedema Procedure: Lymphaticovenous anastomosis (LVA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Quality of Life of Patients With Breast Cancer-related Lymphedema by Lymphaticovenous Anastomosis (LVA): A Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
No Intervention: Complex decongestive therapy
Group A will continue complex decongestive therapy consisting of skin care, manual lymphatic drainage, and compression therapy using compression stockings.
Experimental: Lymphaticovenous anastomosis (LVA)
Group B will undergo an LVA procedure under local anesthesia in surgical daycare setting. Patients are not allowed to wear compression stockings or have decongestive therapy for four weeks after the surgery.
Procedure: Lymphaticovenous anastomosis (LVA)
LVA is a minimally invasive procedure that can be performed under local anesthesia. Indocyanine green (ICG) lymphography is used to visualize the (obstructed) lymphatic vessels. When using the images as a guide, the lymphatic pathways and the sites for incisions for lymphaticovenous anastomoses are marked with a pen. The patient's limb is then prepared for surgery. Under a surgical microscope the lymphatic vessels are identified and viable lymphatic vessels are anastomosed to similarly sized adjacent recipient venules in the subdermal plane.
Other Name: LVA




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cost-effectiveness of LVA compared to complex decongestive therapy [ Time Frame: 24 months ]
    A trial-based economic evaluation is performed to determine the cost-effectiveness of LVA compared to complex decongestive therapy from the societal perspective. Cost data is collected on the patient-level and includes health care related costs, costs to patient and family, and costs due to lost productivity. The primary outcome measure for the effects is the quality-adjusted life year (QALY). Cost-effectiveness is expressed in an incremental cost-effectiveness ratio (ICER) (i.e. cost per QALY gained). In addition, a Budget Impact Analysis (BIA) will be performed from a budget holder perspective.

  2. Excess limb volume [ Time Frame: 24 months ]
    The relative arm volume is measured using the water displacement method (Bravometer), 3D volumetry, and circumference measurement. The volume of the affected arm is compared to the volume of the unaffected arm.

  3. Discontinuation rate conservative therapy [ Time Frame: 24 months ]
    The number of patients who are able to discontinue conservative therapy, i.e. no longer have to wear compression stockings or no more visits to the therapist, will be registered.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790021


Contacts
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Contact: Jop Beugels, MD 0433877481 jop.beugels@mumc.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6526 GA
Contact: Dietmar Ulrich, MD, PhD    0031 24 361 95 94    dietmar.ulrich@radboudumc.nl   
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Joost Wolfs, MD    0031 43 3877481    joost.wolfs@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: René Van der Hulst, MD, PhD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02790021     History of Changes
Other Study ID Numbers: NL67059.068.18
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Breast Cancer Lymphedema
Lymphatic Diseases
Postoperative Complications
Pathologic Processes