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Procedure

Surgical Technique for Preventing Lymphedema After Breast Cancer Surgery

N/A
Waitlist Available
Led By James W Jakub, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled to undergo an axillary lymph node dissection
Be older than 18 years old
Must not have
Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema
Prior ipsilateral axillary radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months following surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to do surgery for breast cancer that may help prevent arm swelling after the surgery.

Who is the study for?
This trial is for English-speaking patients at high risk of needing axillary lymph node dissection (ALND) as judged by their surgeon. It's not for those who've had radiation in the same armpit area, only need a sentinel lymph node biopsy, have been treated or are being treated to prevent arm lymphedema, or are pregnant.
What is being tested?
The study aims to see if adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) when performing ALND can reduce the chances and severity of developing arm lymphedema after surgery in breast cancer and melanoma patients.
What are the potential side effects?
Potential side effects may include complications from surgery such as infection, swelling, pain, numbness or limited range of motion in the affected arm. The specific risks associated with ARM and LVB procedures will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove lymph nodes under my arm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated or am being treated to prevent swelling in my arm(s).
Select...
I have had radiation therapy on the same side as my underarm before.
Select...
I have had surgery to remove lymph nodes under my arm on the same side as my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ALND with ARM +/- LVBExperimental Treatment1 Intervention
Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
Group II: ALND without ARM +/- LVBActive Control1 Intervention
Axillary Lymph Node Dissection (ALND)

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,351 Previous Clinical Trials
3,060,693 Total Patients Enrolled
6 Trials studying Lymphedema
318 Patients Enrolled for Lymphedema
James W Jakub, MDPrincipal InvestigatorMayo Clinic
Mara A. Piltin, DOPrincipal InvestigatorMayo Clinic in Rochester
James W JakubPrincipal InvestigatorMayo Clinic
James W Jakub, M.D.Principal InvestigatorMayo Clinic

Media Library

ALND (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03428581 — N/A
Lymphedema Research Study Groups: ALND with ARM +/- LVB, ALND without ARM +/- LVB
Lymphedema Clinical Trial 2023: ALND Highlights & Side Effects. Trial Name: NCT03428581 — N/A
ALND (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03428581 — N/A
~39 spots leftby Feb 2026
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