Using nerve monitoring to help protect nerves during breast cancer lymph node surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are adults with breast cancer undergoing axillary lymph node dissection. The trial uses intraoperative neuromonitoring, including somatosensory evoked potentials and direct electrical stimulation, and replaces monopolar with bipolar cautery to help locate and protect nerves such as the ICBN and MBCN. The goal is to see if these techniques improve early nerve identification and nerve preservation during surgery. This is a feasibility/interventional assessment conducted at the University of Cincinnati with collaboration from Evokes Neuromonitoring. The study outlines parameters for reliably identifying nerves and minimizing heat spread to reduce neuropathic pain risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients ages 18-70 years old.
2. Pathologically confirmed diagnosis of breast cancer.
3. Undergoing ALND by one of the breast surgeon Sub-Investigators on this study.

Exclusion Criteria:

1. Patients having any previous axillary surgery other than percutaneous breast biopsy and/or SLNB.
2. Prior breast radiation with neuropathy clearly developing after radiation.
3. Patients who have undergone prior chemotherapy and developed post-chemotherapy neuropathy prior to ALND.
4. Patients with any pre-existing neurological conditions affecting nerves, such as neuropathy (peripheral neuropathy, neuropathic pain or nerve injury to upper extremity).
5. Patients taking medications that are known to modify neuropathic pain (eg, gabapentin, pregabalin, duloxetine, venlafaxine, lidocaine patches, capsaicin, opioids, tramadol, NMDA receptor antagonists, clonidine, cannabis, botox).
6. Patients with prior spinal surgery or spinal pathology (cervical spinal stenosis or cervical radiculopathy).
7. Patients with limb-dysfunction.
8. Patients with demyelinating disease.
9. Patients with significant co-morbidities (clotting disorders on anticoagulation, cardiac issues, other conditions that could impact long-term follow-up).
10. Patients that present with pre-operative breast, arm or chest pain ipsilateral to anticipated ALND.
11. Patients who have had prior procedures where IONM failed intraoperatively.
12. Presence of parietal cortical lesion.

Where it's running

• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: UCCC Clinical Trials Office
• Email: cancer@uchealth.com
• Phone: 513-584-7698

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.