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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Lymphedema, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Whether or not a patient has developed Grade 1+ LE

Outcome Time Frame:

During the first year post-operatively

Safety Issue:

No

Principal Investigator

Dennis Holmes

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

1B-09-12

NCT ID:

NCT01276054

Start Date:

December 2010

Completion Date:

October 2011

Related Keywords:

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

Name

Location

USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800