Impact of the ARM Technique on the Prevention of Lymphedema After Axillary Lymphadenectomy: A Multicenter Randomized Clinical Trial (ARM-LIFE)

March 31, 2026 updated by: Carlos Ortega-Expósito, Hospital Universitari de Bellvitge
To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital De Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Breast cancer patients with an indication for axillary lymphadenectomy according to the multidisciplinary team:

  • cN0 with positive sentinel lymph node biopsy (pN+) requiring axillary lymphadenectomy: cT3; More than two axillary macrometastases; or patients undergoing mastectomy without indication for adjuvant radiotherapy
  • cN1: Primary surgery; or after neoadjuvant therapy without complete axillary response and/or positive TAD (ypN+)
  • cN2: Primary surgery; or after neoadjuvant therapy in luminal tumors and/or without complete axillary response in triple-negative or HER2-positive tumors, and/or positive TAD (ypN+)

Exclusion Criteria:

  • Patients with prior axillary radiotherapy
  • Patients with suspected metastatic involvement based on palpation of ARM lymph nodes during the surgical procedure
  • Patients participating in other studies whose primary objective depends on local axillary treatment
  • Patients unwilling to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ALND
Experimental: ARM
Procedure: Axillary Reverse Mapping
During axillary lymphadenectomy, the ARM technique will be incorporated. Prior to surgery, periareolar Tc99 injection will be performed to identify breast sentinel lymph nodes. Fifteen minutes before surgery, 2 mL of indocyanine green tracer will be injected subcutaneously in the medial intermuscular region of the ipsilateral upper limb, followed by gentle massage for 5 minutes. Standard axillary lymphadenectomy will then be performed, preserving ARM lymph nodes located below the axillary vein and lateral to the thoracodorsal pedicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphedema rate
Time Frame: From enrollment to the end of treatment at 2 years
Lymphedema rate
From enrollment to the end of treatment at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR199/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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