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

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ClinicalTrials.gov Identifier: NCT00932035
Recruitment Status : Terminated (Loss of principal investigator)
First Posted : July 2, 2009
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
Study Start Date : June 2009
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932035


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

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00932035     History of Changes
Other Study ID Numbers: 11130
First Posted: July 2, 2009    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017

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