Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation

Official Title: “Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation”

This is a single institution, investigator initiated, department funded pilot and followed by a randomized phase II study. The investigators will plan on seeking grant funding to aid in the funding of this project as well.

The investigators hypothesize that the use of axillary reverse mapping (ARM) to identify and preserve lymphatic channels and nodes draining the arm as an adjunct to Axillary Lymph Node Dissection (ALND) for breast cancer, will reduce lymphedema associated with the procedure and result in improved quality of life.

This is a two phase trial. In the pilot phase, all patients will undergo mapping, but receive the standard ALND. Note will be made of the location of the mapped upper extremity lymphatic drainage (specific aim 1). All upper extremity related nodes identified in this manner will be marked for identification to determine if they contain tumor cells (specific aim 2). A blinded randomized phase will then be undertaken, randomizing patients between the standard operation, utilizing the blue dye at the end of the case, and the experimental procedure, utilizing mapping prior to starting the procedure and preserving all mapped lymphatics. Measurements of arm swelling, as well as survey instruments for arm function and general quality of life will be utilized to compare groups (specific aim 3)

Specific Aims:

1. To determine the proportion of women undergoing ALND at risk for lymphedema by characterizing the location of upper extremity draining lymphatics relative to breast draining lymphatics.

2. To determine if blue lymphatics identified by axillary reverse mapping contain lymph node metastases, and

3. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.

Intervention(s) in this Clinical Trial

• Procedure: Reverse mapping and ALND
  • All patients in this arm will undergo mapping and receive the standard Axillary Lymph Node Dissection
• Procedure: Reverse mapping with blue dye
  • Treatment Group Procedure: 2.5cc of vital blue dye (isosulfan blue typically) will be injected subcutaneously into the medial upper inner arm on the ipsilateral side of the planned axillary dissection. Five minutes of massage will be utilized to encourage the dye to progress through to the axilla via the lymphatic channels. An ALND is then performed per the surgeon's usual technique with the following changes. The ARM-identified lymphatics and lymph nodes will be identified during the case by inspecting for blue dye filling the lymphatics and staining the lymph nodes. These will be preserved wherever feasible, as deemed by the operating surgeon. Clinically suspicious blue lymph nodes may still be taken with the specimen as appropriate.
• Procedure: Standard axillary dissection with blue dye
  • A standard axillary dissection will be performed per the surgeon's preferred technique. At the conclusion of the surgical procedure 2.5cc of vital blue dye will be injected subcutaneously into the medial upper inner arm on the ipsilateral side, prior to patient awakening.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Pilot
  • In the pilot phase, all patients will undergo mapping, but receive the standard ALND. Note will be made of the location of the mapped upper extremity lymphatic drainage (specific aim 1). All upper extremity related nodes identified in this manner will be marked for identification to determine if they contain tumor cells (specific aim 2).
• Active Comparator: Arm mapping
  • Randomized patients will receive the blue dye and the experimental procedure, utilizing mapping prior to starting the procedure and preserving all mapped lymphatics. Measurements of arm swelling, as well as survey instruments for arm function and general quality of life will be utilized to compare groups (specific aim 3)
• No Intervention: Control
  • Patients will receive the standard of care operation. Surgeon will utilize the blue dye at the end of the case to maintain blinded status.

Primary Measures

• Reduced incidence of lymphedema and other surgical related quality of life issues in those undergoing this procedure as compared to the current standard of care.
  • Time Frame: one year
    Safety Issue?: Yes

Inclusion Criteria:

• All patients diagnosed with breast cancer requiring an ALND

Exclusion criteria:

Patients with the following will be excluded:

• Prior lymphedema in either arm,
• Prior history of axillary surgery (except for sentinel node biopsies),
• Prior history of chest/axillary radiation,
• Need for bilateral axillary node dissection
• Prior neurologic deficits (either motor or sensory) in ipsilateral arm,
• Known allergy to vital blue dyes
• Pregnancy
• Inflammatory Breast Cancer

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of California, Davis Other

Overall Clinical Trial Officials and Contacts

Steven Chen, MD Principal Investigator University of California, Davis  

Overall Contact: Abby Olusanya, FNP 916 734 7502 abimbola.olusanya@ucdmc.ucdavis.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00932035

Study ID Number: 200916955

ClinicalTrials.gov Identifier: NCT00932035

Health Authority: United States: Institutional Review Board