Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

July 1, 2014 updated by: University of Southern California

Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

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
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage 0, I, and II Breast Cancer
  • Not pregnant or breastfeeding
  • Breast cancer or prophylactic mastectomy requiring axillary nodal staging
  • Ability to read and/or comprehend consent form and questionnaires
  • Ability to follow-up per protocol
  • Unilateral axillary staging

Exclusion Criteria:

  • Stage 3
  • Previous axillary lymph node dissection
  • Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
  • Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients
  • Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)
  • Previous diagnosis of LE (lymphedema) of either extremity
  • Bilateral axillary staging

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SNB plus ARM or ALND (+/- SNB) plus ARM
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Names:
  • sentinel node biopsy
Radiation: technetium Tc 99m sulfur colloid
Given intradermally and periareolarly
Other Names:
  • Tc 99m Sulfur Colloid
  • Tc-99m SC
Drug: methylene blue
Given subcutaneously
Other Names:
  • MB
  • Azul de Metileno
  • Azul Metile
  • Blu di Metilene
Drug: indocyanine green solution
Given subcutaneously
Other Names:
  • IC-GREEN
  • ICG solution
Procedure: axillary lymph node biopsy
Undergo axillary lymph node biopsy
Other Names:
  • axillary node biopsy
Procedure: bioimpedance spectroscopy
Correlative studies
Other Names:
  • BIS
Other: lymphedema management
Undergo axillary reverse mapping
ACTIVE_COMPARATOR: SNB or ALND (+/- SNB)
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Names:
  • sentinel node biopsy
Radiation: technetium Tc 99m sulfur colloid
Given intradermally and periareolarly
Other Names:
  • Tc 99m Sulfur Colloid
  • Tc-99m SC
Drug: methylene blue
Given subcutaneously
Other Names:
  • MB
  • Azul de Metileno
  • Azul Metile
  • Blu di Metilene
Drug: indocyanine green solution
Given subcutaneously
Other Names:
  • IC-GREEN
  • ICG solution
Procedure: axillary lymph node biopsy
Undergo axillary lymph node biopsy
Other Names:
  • axillary node biopsy
Procedure: bioimpedance spectroscopy
Correlative studies
Other Names:
  • BIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whether or Not a Patient Has Developed Grade 1+ LE
Time Frame: During the first year post-operatively
LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
During the first year post-operatively

Collaborators and Investigators

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

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

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

December 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (ESTIMATE)

January 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1B-09-12
  • NCI-2010-02323 (REGISTRY: CTRP (Clinical Trial Reporting Program))

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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