Preventing Lymphedema in Axillary Lymph Node Dissection

Not Applicable

Active, not recruiting

• Conditions: Lymphedema; Breast Cancer; Melanoma
• Interventions: Procedure: ALND with ARM +/- LVB; Procedure: ALND

• Registration Number: NCT03428581
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-09
• Study Start: 2018-04-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALND with ARM +/- LVB	ALND with ARM +/- LVB	Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
ALND without ARM +/- LVB	ALND	Axillary Lymph Node Dissection (ALND)

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States