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 Overview
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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

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.

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

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

Intervention / Treatment
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* Radiation: technetium Tc 99m sulfur colloid
* Drug: methylene blue
* Drug: indocyanine green solution
* Procedure: sentinel lymph node biopsy
* Procedure: axillary lymph node biopsy
* Procedure: bioimpedance spectroscopy
* Procedure: quality-of-life assessment
* Other: lymphedema management


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNB plus ARM or ALND (+/- SNB) plus ARM<br>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. | Radiation: technetium Tc 99m sulfur colloid<br>* Given intradermally and periareolarly<br>* Other names: Tc-99m SC;Drug: methylene blue<br>* Given subcutaneously<br>* Other names: MB;Drug: indocyanine green solution<br>* Given subcutaneously<br>* Other names: ICG solution;Procedure: sentinel lymph node biopsy<br>* Undergo sentinel lymph node biopsy<br>* Other names: sentinel node biopsy;Procedure: axillary lymph node biopsy<br>* Undergo axillary lymph node biopsy<br>* Other names: axillary node biopsy;Procedure: bioimpedance spectroscopy<br>* Correlative studies<br>* Other names: BIS;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: lymphedema management<br>* Undergo axillary reverse mapping<br>|
| Active Comparator: SNB or ALND (+/- SNB)<br>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. | Radiation: technetium Tc 99m sulfur colloid<br>* Given intradermally and periareolarly<br>* Other names: Tc-99m SC;Drug: methylene blue<br>* Given subcutaneously<br>* Other names: MB;Drug: indocyanine green solution<br>* Given subcutaneously<br>* Other names: ICG solution;Procedure: sentinel lymph node biopsy<br>* Undergo sentinel lymph node biopsy<br>* Other names: sentinel node biopsy;Procedure: axillary lymph node biopsy<br>* Undergo axillary lymph node biopsy<br>* Other names: axillary node biopsy;Procedure: bioimpedance spectroscopy<br>* Correlative studies<br>* Other names: BIS;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |