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Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients with arm lymphatics above, at, or below the axillary vein (Pilot)

Outcome Description:

A Fisher's exact test with a one-sided alpha of 0.05 will be used.

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Steven Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11130

NCT ID:

NCT00932035

Start Date:

June 2009

Completion Date:

December 2017

Related Keywords:

  • Breast Cancer
  • breast cancer
  • axillary mapping
  • lymphedema
  • Breast Neoplasms
  • Lymphedema

Name

Location

City of Hope Medical CenterDuarte, California  91010
University of North CarolinaChapel Hill, North Carolina  27599
University of California, Davis Medical CenterSacramento, California