Preventing Lymphedema in Axillary Lymph Node Dissection

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03428581
• Other study ID #: 16-010491
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: February 28, 2026

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema
• Melanoma

Intervention

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.
• ALND
Prospective and retrospective subjects undergoing an ALND.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity	Bilateral Limb volume measurements	36 months following surgery
Primary	Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity	Validated patient reported surveys	36 months following surgery

External Links

•   Mayo Clinic Clinical Trials