Breast Cancer, Lymphedema Arm
Conditions
Brief summary
To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.
Interventions
PROCEDUREAxillary 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.
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema rate | From enrollment to the end of treatment at 2 years | Lymphedema rate |
Countries
Spain
Outcome results
None listed