Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

Lymphedema Recurrent Breast Cancer Stage IA Breast Cancer +2 more

TERMINATED PHASE2

Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases

NCT03281720

Breast Cancer

COMPLETED NA

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

NCT03927027

Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III

ACTIVE_NOT_RECRUITING PHASE3

Lymphedema Surveillance Study

NCT02743858

Breast Cancer Lymphedema

RECRUITING

Reverse Axillary Mapping in Breast Radiation Treatment Planning

NCT04292860

Breast Cancer Lymphedema

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.

OUTLINE: This is a phase I study followed by a randomized phase II study.

PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.

RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

After completion of study treatment, patients are followed up periodically.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (reverse mapping guided axillary lymph node dissection)

Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.

Group Type EXPERIMENTAL

axillary lymph node dissection

Intervention Type PROCEDURE

Undergo reverse mapping-guided axillary lymph node dissection

isosulfan blue based lymphatic mapping

Intervention Type DRUG

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Arm II (control)

Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.

Group Type ACTIVE_COMPARATOR

isosulfan blue based lymphatic mapping

Intervention Type DRUG

axillary lymph node dissection

Intervention Type PROCEDURE

Undergo standard axillary lymph node dissection

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

axillary lymph node dissection

Undergo reverse mapping-guided axillary lymph node dissection

Intervention Type PROCEDURE

isosulfan blue based lymphatic mapping

Intervention Type DRUG

axillary lymph node dissection

Undergo standard axillary lymph node dissection

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

isosulfan blue dye Lymphazurin blue dye isosulfan blue dye Lymphazurin blue dye isosulfan blue dye Lymphazurin blue dye

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer

Exclusion Criteria

* Prior lymphedema in either arm
* Prior history of axillary surgery (except for sentinel node biopsies)
* Prior history of chest/axillary radiation
* Need for bilateral axillary node dissection surgery
* Prior neurologic deficits (either motor or sensory) in ipsilateral arm
* Known allergy to vital blue dyes
* No prior diagnosis of inflammatory breast cancer
* Cannot be pregnant or planning to continue breast-feeding immediately after surgery

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No