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

Breast Cancer Clinical Trial

Official title:

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932035
• Other study ID #: 11130
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 29, 2009
• Last updated: May 28, 2014
• Start date: June 2009

Study information

• Verified date: May 2014
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• axillary lymph node dissection
Undergo reverse mapping-guided axillary lymph node dissection

Drug:
• isosulfan blue based lymphatic mapping

Procedure:
• axillary lymph node dissection
Undergo standard axillary lymph node dissection
• quality-of-life assessment
Ancillary studies

Other:
• Questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	City of Hope Medical Center	Duarte	California
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with arm lymphatics above, at, or below the axillary vein (Pilot)	A Fisher's exact test with a one-sided alpha of 0.05 will be used.	Up to 4 years	No
Primary	Percentage of patients with positive axillary reverse mapping (ARM) identified nodes	A Fisher's exact test with a one-sided alpha of 0.05 will be used.	Up to 4 years	No
Primary	Incidence of lymphedema	Differences between groups for lymphedema will be evaluated using chi-squared tests.	Up to 4 years	No
Primary	Surgical related quality of life measured using Short Form (SF)-8 Quality of Life Survey Instrument	A Fisher's exact test with a one-sided alpha of 0.05 will be used.	Up to 4 years	No
Secondary	Tumor status of blue lymph nodes as tumor bearing or non-tumor bearing (Pilot)	Patient and tumor characteristics that correlate with successful mappings will be performed using univariate correlation and logistic regression for multivariate analysis.	Up to 4 years	No
Secondary	Predictors of lymphedema, including patient age, body mass index, tumor characteristics, and location of arm lymphatics	Chi-squared testing and student t-tests will be utilized to evaluate the differences in demographics and tumor characteristics between groups.	Up to 4 years	No