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.

This study has been terminated.
(P.I. left)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01276054
First received: January 11, 2011
Last updated: July 1, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Lymphedema
Recurrent Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Radiation: technetium Tc 99m sulfur colloid
Drug: methylene blue
Drug: indocyanine green solution
Procedure: sentinel lymph node biopsy
Procedure: axillary lymph node biopsy
Procedure: bioimpedance spectroscopy
Procedure: quality-of-life assessment
Other: lymphedema management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Whether or Not a Patient Has Developed Grade 1+ LE [ Time Frame: During the first year post-operatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:
  • Azul de Metileno
  • Azul Metile
  • Blu di Metilene
  • MB
Drug: indocyanine green solution
Given subcutaneously
Other Names:
  • IC-GREEN
  • ICG solution
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy
Procedure: axillary lymph node biopsy
Undergo axillary lymph node biopsy
Other Name: axillary node biopsy
Procedure: bioimpedance spectroscopy
Correlative studies
Other Name: BIS
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
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.
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:
  • Azul de Metileno
  • Azul Metile
  • Blu di Metilene
  • MB
Drug: indocyanine green solution
Given subcutaneously
Other Names:
  • IC-GREEN
  • ICG solution
Procedure: sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Other Name: sentinel node biopsy
Procedure: axillary lymph node biopsy
Undergo axillary lymph node biopsy
Other Name: axillary node biopsy
Procedure: bioimpedance spectroscopy
Correlative studies
Other Name: BIS
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276054

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Dennis Holmes University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01276054     History of Changes
Other Study ID Numbers: 1B-09-12, NCI-2010-02323
Study First Received: January 11, 2011
Results First Received: July 1, 2014
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphedema
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pharmaceutical Solutions
Technetium Tc 99m Sulfur Colloid
Methylene Blue
Therapeutic Uses
Pharmacologic Actions
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014