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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00932035
First received: June 29, 2009
Last updated: May 28, 2014
Last verified: May 2014

June 29, 2009
May 28, 2014
June 2009
May 2014   (final data collection date for primary outcome measure)
  • 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.
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00932035 on ClinicalTrials.gov Archive Site
  • 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.
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Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Breast Cancer
  • 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
  • Procedure: quality-of-life assessment
    Ancillary studies
  • Other: Questionnaire administration
    Ancillary studies
  • 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.
    Interventions:
    • Procedure: axillary lymph node dissection
    • Drug: isosulfan blue based lymphatic mapping
    • Procedure: quality-of-life assessment
    • Other: Questionnaire administration
  • Active Comparator: Arm II (control)
    Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
    Interventions:
    • Drug: isosulfan blue based lymphatic mapping
    • Procedure: axillary lymph node dissection
    • Procedure: quality-of-life assessment
    • Other: Questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932035
11130
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Steven Chen, MD City of Hope Medical Center
City of Hope Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP