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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.

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01276054
Enrollment
4
Registered
2011-01-13
Start date
2010-12-31
Completion date
2011-10-31
Last updated
2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

RADIATIONtechnetium Tc 99m sulfur colloid

Given intradermally and periareolarly

DRUGmethylene blue

Given subcutaneously

DRUGindocyanine green solution

Given subcutaneously

PROCEDUREsentinel lymph node biopsy

Undergo sentinel lymph node biopsy

PROCEDUREaxillary lymph node biopsy

Undergo axillary lymph node biopsy

PROCEDUREbioimpedance spectroscopy

Correlative studies

PROCEDUREquality-of-life assessment

Ancillary studies

OTHERlymphedema management

Undergo axillary reverse mapping

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Whether or Not a Patient Has Developed Grade 1+ LEDuring the first year post-operativelyLE 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.

Countries

United States

Participant flow

Recruitment details

Recruitment for this trial opened in December 2010 and closed in June 2011 at which time the protocol was terminated due to the departure of the Principal Investigator.

Pre-assignment details

The study has no pre-assignment.

Participants by arm

ArmCount
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. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies lymphedema management: Undergo axillary reverse mapping
2
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. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies
2
Total4

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNo one to oversee trial after P.I. left22

Baseline characteristics

CharacteristicSNB Plus ARM or ALND (+/- SNB) Plus ARMSNB or ALND (+/- SNB)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
2 participants2 participants4 participants
Sex: Female, Male
Female
2 Participants2 Participants4 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 22 / 2
serious
Total, serious adverse events
2 / 22 / 2

Outcome results

Primary

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.

Time frame: During the first year post-operatively

Population: Unable to analyze due to early termination of the study

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026