Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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.

NCTNCT01276054Other id1B-09-12Other idNCI-2010-02323

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: P.I. left

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 4 participants (actual)
Sponsor: University of Southern California · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2010
Primary completion: Oct 2011
Completion: Oct 2011
First posted: 13 Jan 2011 (estimated)
Last update posted: 1 Aug 2014 (estimated)
Conditions: Lymphedema · Recurrent Breast Cancer · Stage IA Breast Cancer · Stage IB Breast Cancer · Stage II Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph 2
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.
NCT01276054
Dec 2010 to Oct 2011
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

technetium Tc 99m sulfur colloidRadiation
methylene blueDrug
indocyanine green solutionDrug
sentinel lymph node biopsyProcedure
axillary lymph node biopsyProcedure
bioimpedance spectroscopyProcedure
quality-of-life assessmentProcedure
lymphedema managementOther

Arms2

Experimental
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.
Active comparator
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Whether or Not a Patient Has Developed Grade 1+ LE
Time frame · During the first year post-operatively
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· During the first year post-operatively

Whether or Not a Patient Has Developed Grade 1+ LE

Group	Value
SNB Plus ARM or ALND (+/- SNB) Plus ARM	not posted
SNB or ALND (+/- SNB)	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SNB Plus ARM or ALND (+/- SNB) Plus ARMPatients 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 / 2	2 / 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 / 2	2 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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