Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07515300

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

To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lymphedema Arm Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary Reverse Mapping

Procedure

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.

Primary outcomes

  1. Lymphedema rate

    Time frame: From enrollment to the end of treatment at 2 years

    Lymphedema rate

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Acronym: ARM-LIFE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.