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.

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SNB plus ARM or ALND (+/- SNB) plus ARM

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 an axillary reverse mapping.

Group Type EXPERIMENTAL

technetium Tc 99m sulfur colloid

Intervention Type RADIATION

Given intradermally and periareolarly

methylene blue

Intervention Type DRUG

Given subcutaneously

indocyanine green solution

Intervention Type DRUG

Given subcutaneously

sentinel lymph node biopsy

Intervention Type PROCEDURE

Undergo sentinel lymph node biopsy

axillary lymph node biopsy

Intervention Type PROCEDURE

Undergo axillary lymph node biopsy

bioimpedance spectroscopy

Intervention Type PROCEDURE

Correlative studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

lymphedema management

Intervention Type OTHER

Undergo axillary reverse mapping

SNB or ALND (+/- SNB)

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.

Group Type ACTIVE_COMPARATOR

technetium Tc 99m sulfur colloid

Intervention Type RADIATION

Given intradermally and periareolarly

methylene blue

Intervention Type DRUG

Given subcutaneously

indocyanine green solution

Intervention Type DRUG

Given subcutaneously

sentinel lymph node biopsy

Intervention Type PROCEDURE

Undergo sentinel lymph node biopsy

axillary lymph node biopsy

Intervention Type PROCEDURE

Undergo axillary lymph node biopsy

bioimpedance spectroscopy

Intervention Type PROCEDURE

Correlative studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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technetium Tc 99m sulfur colloid

Given intradermally and periareolarly

Intervention Type RADIATION

methylene blue

Given subcutaneously

Intervention Type DRUG

indocyanine green solution

Given subcutaneously

Intervention Type DRUG

sentinel lymph node biopsy

Undergo sentinel lymph node biopsy

Intervention Type PROCEDURE

axillary lymph node biopsy

Undergo axillary lymph node biopsy

Intervention Type PROCEDURE

bioimpedance spectroscopy

Correlative studies

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

lymphedema management

Undergo axillary reverse mapping

Intervention Type OTHER

Other Intervention Names

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Tc 99m Sulfur Colloid Tc-99m SC Azul de Metileno Azul Metile Blu di Metilene MB IC-GREEN ICG solution sentinel node biopsy axillary node biopsy BIS quality of life assessment

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No