Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

May 5, 2017 updated by: City of Hope Medical Center

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. 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.

OUTLINE: This is a phase I study followed by a randomized phase II study.

PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.

RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

After completion of study treatment, patients are followed up periodically.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-1350
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer

Exclusion Criteria:

  • 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 surgery
  • Prior neurologic deficits (either motor or sensory) in ipsilateral arm
  • Known allergy to vital blue dyes
  • No prior diagnosis of inflammatory breast cancer
  • Cannot be pregnant or planning to continue breast-feeding immediately after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I (reverse mapping guided axillary lymph node dissection)
Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
Other: Questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Procedure: axillary lymph node dissection
Undergo reverse mapping-guided axillary lymph node dissection
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye
Drug: isosulfan blue based lymphatic mapping
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye
Procedure: axillary lymph node dissection
Undergo standard axillary lymph node dissection
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye
ACTIVE_COMPARATOR: Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
Other: Questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Procedure: axillary lymph node dissection
Undergo reverse mapping-guided axillary lymph node dissection
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye
Drug: isosulfan blue based lymphatic mapping
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye
Procedure: axillary lymph node dissection
Undergo standard axillary lymph node dissection
Other Names:
  • isosulfan blue dye
  • Lymphazurin blue dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein
Time Frame: Up to 4 years
A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.
Up to 4 years
Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes
Time Frame: Up to 4 years
A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.
Up to 4 years
Percentage of Patients With Lymphedema
Time Frame: Up to 4 years
Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steven Chen, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (ESTIMATE)

July 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11130 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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