Impact of the ARM Technique on the Prevention of Lymphedema After Axillary Lymphadenectomy: A Mul… (NCT07515300) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of the ARM Technique on the Prevention of Lymphedema After Axillary Lymphadenectomy: A Multicenter Randomized Clinical Trial
Spain100 participantsStarted 2026-03-01
Plain-language summary
To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Lymphedema rate
Timeframe: From enrollment to the end of treatment at 2 years