Clinical trial · Interventional
Impact of the ARM Technique on the Prevention of Lymphedema After Axillary Lymphadenectomy: A Multicenter Randomized Clinical Trial
NCT07515300CI-TRIAL-00107483ARM-LIFEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Reverse Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- ALND
- type
- EXPERIMENTAL
- label
- ARM
- interventionNames
- Procedure: Axillary Reverse Mapping
Primary outcomes (1)
- measure
- Lymphedema rate
- timeFrame
- From enrollment to the end of treatment at 2 years
- description
- Lymphedema rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDCarlos OE, Maria P, Miriam C, Catalina F, Hector PM, Juan A, Ana B, Sira S, Jan B, Marina AP, Sonia P, Jordi P, Amparo GT. Axillary Reverse Mapping Using Indocyanine Green in Breast Cancer: Standardization of the Technique. Clin Breast Cancer. 2025 Apr;25(3):268-276. doi: 10.1016/j.clbc.2024.12.003. Epub 2024 Dec 7. PMID 39755446