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.

University of Southern California

Status and phase: Terminated; Phase 2

Conditions: Stage IB Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Lymphedema; Recurrent Breast Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01276054

1B-09-12

NCI-2010-02323 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Radiation: technetium Tc 99m sulfur colloid

Procedure: quality-of-life assessment

Procedure: axillary lymph node biopsy

Drug: indocyanine green solution

Procedure: sentinel lymph node biopsy

Procedure: bioimpedance spectroscopy

Drug: methylene blue

Other: lymphedema management

SNB or ALND (+/- SNB)

Active Comparator group

Description:

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.

Treatment:

Radiation: technetium Tc 99m sulfur colloid

Procedure: quality-of-life assessment

Procedure: axillary lymph node biopsy

Drug: indocyanine green solution

Procedure: sentinel lymph node biopsy

Procedure: bioimpedance spectroscopy

Drug: methylene blue