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Clinical Trials in Spain / NCT07515300
Active, not recruiting Not applicable

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

NCT07515300 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Not applicable
Started
2026-03-01
Last updated
2026-04-07

Condition(s) studied

Breast CancerLymphedema Arm

Investigational drug(s) / intervention(s)

Axillary Reverse Mapping

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Lymphedema rate — From enrollment to the end of treatment at 2 years
    Lymphedema rate

Trial sites (1)

FacilityCityRegionStatus
Hospital de Bellvitge L'Hospitalet de Llobregat Barcelona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07515300 on ClinicalTrials.gov ↗ ← All trials in Spain