Preventing Lymphedema in Axillary Lymph Node Dissection

Overview

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Full Title of Study: “Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2021

Detailed Description

All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

Interventions

  • Procedure: ALND with ARM +/- LVB
    • Subjects will undergo removal of the lymph nodes in the underarm or “axilla” area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.
  • Procedure: ALND
    • Prospective and retrospective subjects undergoing an ALND.

Arms, Groups and Cohorts

  • Experimental: ALND with ARM +/- LVB
    • Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
  • Active Comparator: ALND without ARM +/- LVB
    • Axillary Lymph Node Dissection (ALND)

Clinical Trial Outcome Measures

Primary Measures

  • Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
    • Time Frame: 36 months following surgery
    • Bilateral Limb volume measurements
  • Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
    • Time Frame: 36 months following surgery
    • Validated patient reported surveys

Participating in This Clinical Trial

Inclusion Criteria

  • Patients scheduled to undergo an axillary lymph node dissection
  • Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
  • English speaking

Exclusion Criteria

  • Prior ipsilateral axillary lymph node dissection
  • Prior ipsilateral axillary radiation
  • Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
  • Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
  • Pregnant patients cannot participate in the substudy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: James W. Jakub, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • James W Jakub, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Sheri Ramaker, R.N., 507-538-6984, ramaker.sheri@mayo.edu

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