Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Lymphedema Clinical Trial

Official title:

Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01276054
• Other study ID #: 1B-09-12
• Secondary ID: NCI-2010-02323
• Status: Terminated
• Phase: Phase 2
• First received: January 11, 2011
• Last updated: July 1, 2014
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

Description:

PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage 0, I, and II Breast Cancer

• Not pregnant or breastfeeding

• Breast cancer or prophylactic mastectomy requiring axillary nodal staging

• Ability to read and/or comprehend consent form and questionnaires

• Ability to follow-up per protocol

• Unilateral axillary staging

Exclusion Criteria:

• Stage 3

• Previous axillary lymph node dissection

• Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration

• Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients

• Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)

• Previous diagnosis of LE (lymphedema) of either extremity

• Bilateral axillary staging

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema
• Recurrent Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

Intervention

Radiation:
• technetium Tc 99m sulfur colloid
Given intradermally and periareolarly

Drug:
• methylene blue
Given subcutaneously
• indocyanine green solution
Given subcutaneously

Procedure:
• sentinel lymph node biopsy
Undergo sentinel lymph node biopsy
• axillary lymph node biopsy
Undergo axillary lymph node biopsy
• bioimpedance spectroscopy
Correlative studies
• quality-of-life assessment
Ancillary studies

Other:
• lymphedema management
Undergo axillary reverse mapping

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether or Not a Patient Has Developed Grade 1+ LE	LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.	During the first year post-operatively	No