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Trial record 7 of 78 for:    Recruiting, Not yet recruiting, Available Studies | "Lymphedema"

Lymphaticovenous Anastomosis for Breast Cancer-related Lymphedema

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ClinicalTrials.gov Identifier: NCT02790021
Recruitment Status : Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Rationale: Breast cancer-related lymphedema (BCRL) is one of the most underestimated complications of breast 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.

Objective: To improve breast cancer survivorship by reducing/eliminating one of the most debilitating upper-body morbidities related to breast cancer treatment: chronic lymphedema of the arm.

Study design: A multicenter, randomized controlled trial (RCT) carried out in the Maastricht University Medical Center, VieCuri Medical Center and Zuyderland Medical Center in the Netherlands.

Study population: The study population includes all women over 18 years old who underwent surgical treatment for early stage breast cancer with an SLNB or ALND, or who received axillary radiotherapy, presenting with an early stage lymphedema of the arm (stage 1 and 2a on the ISL classification for lymphedema).

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 lymphaticovenous anastomoses (LVA) by a plastic surgeon.

Main study parameters/endpoints: The main study parameters are the difference in excess limb volume (ELV) after one of both treatments, the effect of treatment on the quality of life and the cost-effectiveness of both treatments.

Study-specific procedures: After randomization the follow-up moments will be at 3, 6, 9, 12, 18 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, the investigators will measure the volume of the treated and untreated side using the water displacement method and circumference measurement. A lymphoscintigraphy is made at inclusion, after 12 months and after 24 months. Lastly, the subjects will be asked at certain time points to fill in five questionnaires: Lymph-ICF, EORTC QLQ-C30, EORTC QLQ-BR23, EQ-5D-5L and the DASH questionnaire.


Condition or disease Intervention/treatment
Lymphedema Procedure: Lymphaticovenous anastomosis (LVA)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Quality of Survivorship for Breast Cancer-related Lymphedema by Lymphaticovenous Anastomosis: A Randomized Controlled Trial
Anticipated Study Start Date : July 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Relative arm volume of the affected compared to the unaffected arm [ Time Frame: 12 months ]
    The relative arm volume is measured using the water displacement method (Bravometer). The volume of the affected arm is compared to the volume of the unaffected arm.


Secondary Outcome Measures :
  1. Change in quality of life after treatment using the EQ-5D-5L questionnaire [ Time Frame: 12 months ]
    The quality of life will be measured using the EQ-5D-5L questionnaire, resulting in an index score for the change in quality of life between 0 and 1. This index score will also be used to calculate quality-adjusted life years.

  2. Change in quality of life after treatment using the EORTC QLQ-C30 questionnaire [ Time Frame: 12 months ]
    The quality of life will be measured using the EORTC QLQ-C30 questionnaire, resulting in a score for the quality of life between 0 to 100. The results after twelve months can be compared to the baseline quality of life.

  3. Change in quality of life after treatment using the EORTC QLQ-BR23 questionnaire [ Time Frame: 12 months ]
    The quality of life will be measured using the EORTC QLQ-BR23 questionnaire, resulting in a score for the quality of life between 0 to 100. The results after twelve months can be compared to the baseline quality of life.

  4. Subjective symptoms related to lymphedema using the Lymph-ICF questionnaire [ Time Frame: 12 months ]
    The subjective symptoms related to lymphedema will be measured using the Lymphedema Functioning, Disability and Health (Lymph-ICF) questionnaire. A change in the subjective symptoms will be assessed by comparing the subjective symptoms before and after treatment.

  5. Disabilities of the arm, shoulder and hand using the DASH questionnaire [ Time Frame: 12 months ]
    The disabilities of the arm, shoulder and hand will be assessed using the Disabilities of the arm, shoulder and hand (DASH) questionnaire. The results will be compared before and after treatment.

  6. Cost-effectiveness of LVA compared to complex decongestive therapy [ Time Frame: 12 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.


Eligibility Criteria

Information from the National Library of Medicine

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

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 or 2a on ISL classification)
  • Excess limb volume ≥10% (relative volume of the unaffected arm compared to the affected arm)
  • Previously had three months conservative therapy (standard of care)
  • Primary breast cancer
  • Unilateral disease / treatment
  • Informed consent

Exclusion Criteria:

  • Male sex
  • Stage 2b or 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
More Information

Responsible Party: Rene van der Hulst, Prof. dr., Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02790021     History of Changes
Other Study ID Numbers: NL56477.068.16
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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