Preventing Lymphedema in Axillary Lymph Node Dissection

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03428581

Collaborator

(none)

264

Enrollment

Locations

Arms

57.8

Anticipated Duration (Months)

132

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphedema Breast Cancer Melanoma	Procedure: ALND with ARM +/- LVB Procedure: ALND	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 10, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALND with ARM +/- LVB Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.	Procedure: ALND with ARM +/- LVB 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.
Active Comparator: ALND without ARM +/- LVB Axillary Lymph Node Dissection (ALND)	Procedure: ALND Prospective and retrospective subjects undergoing an ALND.

Arm

Intervention/Treatment

Experimental: ALND with ARM +/- LVB

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

Procedure: ALND with ARM +/- LVB

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.

Active Comparator: ALND without ARM +/- LVB

Axillary Lymph Node Dissection (ALND)

Procedure: ALND

Prospective and retrospective subjects undergoing an ALND.

Outcome Measures

Primary Outcome Measures

Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity [36 months following surgery]
Bilateral Limb volume measurements
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity [36 months following surgery]
Validated patient reported surveys

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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