Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00932035

Purpose

This is a single institution, investigator initiated, department funded pilot and followed by a randomized phase II study. The investigators will plan on seeking grant funding to aid in the funding of this project as well.

The investigators hypothesize that the use of axillary reverse mapping (ARM) to identify and preserve lymphatic channels and nodes draining the arm as an adjunct to Axillary Lymph Node Dissection (ALND) for breast cancer, will reduce lymphedema associated with the procedure and result in improved quality of life.

Condition	Intervention	Phase
Breast Cancer	Procedure: Reverse mapping and ALND Procedure: Reverse mapping with blue dye Procedure: Standard axillary dissection with blue dye	Phase I Phase II

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema Surgery

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	70
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pilot: Experimental In the pilot phase, all patients will undergo mapping, but receive the standard ALND. Note will be made of the location of the mapped upper extremity lymphatic drainage (specific aim 1). All upper extremity related nodes identified in this manner will be marked for identification to determine if they contain tumor cells (specific aim 2).	Procedure: Reverse mapping and ALND All patients in this arm will undergo mapping and receive the standard Axillary Lymph Node Dissection
Arm mapping: Active Comparator Randomized patients will receive the blue dye and the experimental procedure, utilizing mapping prior to starting the procedure and preserving all mapped lymphatics. Measurements of arm swelling, as well as survey instruments for arm function and general quality of life will be utilized to compare groups (specific aim 3)	Procedure: Reverse mapping with blue dye Treatment Group Procedure: 2.5cc of vital blue dye (isosulfan blue typically) will be injected subcutaneously into the medial upper inner arm on the ipsilateral side of the planned axillary dissection. Five minutes of massage will be utilized to encourage the dye to progress through to the axilla via the lymphatic channels. An ALND is then performed per the surgeon's usual technique with the following changes. The ARM-identified lymphatics and lymph nodes will be identified during the case by inspecting for blue dye filling the lymphatics and staining the lymph nodes. These will be preserved wherever feasible, as deemed by the operating surgeon. Clinically suspicious blue lymph nodes may still be taken with the specimen as appropriate.
Control: No Intervention Patients will receive the standard of care operation. Surgeon will utilize the blue dye at the end of the case to maintain blinded status.	Procedure: Standard axillary dissection with blue dye A standard axillary dissection will be performed per the surgeon's preferred technique. At the conclusion of the surgical procedure 2.5cc of vital blue dye will be injected subcutaneously into the medial upper inner arm on the ipsilateral side, prior to patient awakening.

Detailed Description:

This is a two phase trial. In the pilot phase, all patients will undergo mapping, but receive the standard ALND.

Note will be made of the location of the mapped upper extremity lymphatic drainage (specific aim 1). All upper extremity related nodes identified in this manner will be marked for identification to determine if they contain tumor cells (specific aim 2). A blinded randomized phase will then be undertaken, randomizing patients between the standard operation, utilizing the blue dye at the end of the case, and the experimental procedure, utilizing mapping prior to starting the procedure and preserving all mapped lymphatics. Measurements of arm swelling, as well as survey instruments for arm function and general quality of life will be utilized to compare groups (specific aim 3)

Specific Aims:

To determine the proportion of women undergoing ALND at risk for lymphedema by characterizing the location of upper extremity draining lymphatics relative to breast draining lymphatics.
To determine if blue lymphatics identified by axillary reverse mapping contain lymph node metastases, and
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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients diagnosed with breast cancer requiring an ALND

Exclusion criteria:

Patients with the following will be excluded:

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
Prior neurologic deficits (either motor or sensory) in ipsilateral arm,
Known allergy to vital blue dyes
Pregnancy
Inflammatory Breast Cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932035

Contacts

Contact: Abby Olusanya, FNP

916 734 7502

abimbola.olusanya@ucdmc.ucdavis.edu

Locations

United States, California
University of California, Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Contact: Abby Olusanya, FNP 916-734-7502 abimbola.olusanya@ucdmc.ucdavis.edu
Principal Investigator: Steven Chen, MD
Sub-Investigator: Richard Bold, MD
Sub-Investigator: Steve Martinez, MD
Sub-Investigator: Vijay Khatri, MD
Sub-Investigator: Robert Canter, MD

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Steven Chen, MD

University of California, Davis

More Information

No publications provided

Responsible Party:	University of California ( Steven Chen, MD )
Study ID Numbers:	200916955, Chen9551
Study First Received:	June 29, 2009
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00932035 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

breast cancer
axillary mapping
lymphedema

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Lymphedema
Lymphatic Diseases
Neoplasms
Neoplasms by Site

Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009