Clinical trial NCT00932035: Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
Official title: Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
axillary mapping
lymphedema
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-02
Enrollment: 39
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein
timeFrame: Up to 4 years
measure: Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes
timeFrame: Up to 4 years
measure: Percentage of Patients With Lymphedema
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: City of Hope Medical Center
name: Steven Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: