Clinical trial NCT01276054: 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.
Official title: Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphedema
Recurrent Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-01-13
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Whether or Not a Patient Has Developed Grade 1+ LE
timeFrame: During the first year post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Dennis Holmes
role: PRINCIPAL_INVESTIGATOR
References: