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

This study is currently recruiting participants.
Verified April 2013 by City of Hope Medical Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00932035
First received: June 29, 2009
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Procedure: axillary lymph node dissection
Drug: isosulfan blue based lymphatic mapping
Procedure: quality-of-life assessment
Other: Questionnaire administration
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Percentage of patients with arm lymphatics above, at, or below the axillary vein (Pilot) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    A Fisher's exact test with a one-sided alpha of 0.05 will be used.

  • Percentage of patients with positive axillary reverse mapping (ARM) identified nodes [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    A Fisher's exact test with a one-sided alpha of 0.05 will be used.

  • Incidence of lymphedema [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Differences between groups for lymphedema will be evaluated using chi-squared tests.

  • Surgical related quality of life measured using Short Form (SF)-8 Quality of Life Survey Instrument [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    A Fisher's exact test with a one-sided alpha of 0.05 will be used.


Secondary Outcome Measures:
  • Tumor status of blue lymph nodes as tumor bearing or non-tumor bearing (Pilot) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Patient and tumor characteristics that correlate with successful mappings will be performed using univariate correlation and logistic regression for multivariate analysis.

  • Predictors of lymphedema, including patient age, body mass index, tumor characteristics, and location of arm lymphatics [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Chi-squared testing and student t-tests will be utilized to evaluate the differences in demographics and tumor characteristics between groups.


Estimated Enrollment: 97
Study Start Date: June 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: quality-of-life assessment
Ancillary studies
Other: Questionnaire administration
Ancillary studies
Active Comparator: Arm II (control)
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
 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
Procedure: quality-of-life assessment
Ancillary studies
Other: Questionnaire administration
Ancillary studies

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932035

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Steven Chen, MD     800-826-4673        
Principal Investigator: Steven Chen, MD            
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Jaskaran Birak     916-734-2620     jaskaran.birak@ucdmc.ucdavis.edu    
Principal Investigator: Richard J. Bold, MD            
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599-1350
Contact: Mark Kramer     919-966-2629     mkramer@med.unc.edu    
Principal Investigator: Keith D. Amos, MD            
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Chen, MD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00932035     History of Changes
Other Study ID Numbers: 11130
Study First Received: June 29, 2009
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
breast cancer
axillary mapping
lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013