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Preventing Lymphedema in Axillary Lymph Node Dissection

Primary Purpose

Lymphedema, Breast Cancer, Melanoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ALND with ARM +/- LVB

ALND

About this trial

This is an interventional prevention trial for Lymphedema focused on measuring Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

Patients scheduled to undergo an axillary lymph node dissection
Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
English speaking

Exclusion Criteria

Prior ipsilateral axillary lymph node dissection
Prior ipsilateral axillary radiation
Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
Pregnant patients cannot participate in the substudy

Sites / Locations

Mayo Clinic in Florida
Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALND with ARM +/- LVB

ALND without ARM +/- LVB

Arm Description

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Axillary Lymph Node Dissection (ALND)

Outcomes

Primary Outcome Measures

Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity

Bilateral Limb volume measurements

Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity

Validated patient reported surveys

Secondary Outcome Measures

Full Information

NCT ID

NCT03428581

First Posted

October 23, 2017

Last Updated

October 20, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03428581

Brief Title

Preventing Lymphedema in Axillary Lymph Node Dissection

Official Title

Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 10, 2018 (Actual)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Detailed Description

All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema, Breast Cancer, Melanoma

Keywords

Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

264 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALND with ARM +/- LVB

Arm Type

Experimental

Arm Description

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Arm Title

ALND without ARM +/- LVB

Arm Type

Active Comparator

Arm Description

Axillary Lymph Node Dissection (ALND)

Intervention Type

Procedure

Intervention Name(s)

ALND with ARM +/- LVB

Intervention Description

Subjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.

Intervention Type

Procedure

Intervention Name(s)

ALND

Intervention Description

Prospective and retrospective subjects undergoing an ALND.

Primary Outcome Measure Information:

Title

Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity

Description

Bilateral Limb volume measurements

Time Frame

36 months following surgery

Title

Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity

Description

Validated patient reported surveys

Time Frame

36 months following surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patients scheduled to undergo an axillary lymph node dissection Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings English speaking Exclusion Criteria Prior ipsilateral axillary lymph node dissection Prior ipsilateral axillary radiation Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema. Pregnant patients cannot participate in the substudy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W Jakub, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Preventing Lymphedema in Axillary Lymph Node Dissection

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