6 Participants NeededMy employer runs this trial

Intraoperative Neuromonitoring for Breast Cancer Surgery

UC
DH
Overseen ByDale Horne
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technique during breast cancer surgery to identify nerves that may cause post-surgery pain. Researchers aim to determine if a special monitoring method, known as the IONM procedure (Intraoperative Neuromonitoring), can detect these nerves early, potentially reducing pain after surgery. The trial targets breast cancer patients requiring a specific surgery called axillary lymph node dissection (ALND) who have not undergone previous surgery or radiation affecting nerves.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes and reduce pain for future patients.

Do I need to stop taking my current medications for the trial?

If you are taking medications known to modify neuropathic pain, such as gabapentin, pregabalin, or opioids, you will need to stop taking them to participate in this trial.

What prior data suggests that this IONM procedure is safe for breast cancer surgery?

Research has shown that intraoperative neuromonitoring (IONM) is generally safe and well-tolerated in many surgeries. IONM uses small sensors to monitor nerve activity, helping to prevent nerve damage during surgery. It has improved safety in other surgeries by reducing the risk of nerve injury. Although specific data on using IONM during axillary lymph node dissection (ALND) in breast cancer is limited, its safety in similar surgeries suggests it is likely well-tolerated.

For those considering participation in a trial using IONM, it is reassuring that this technique has a history of safe use in other surgeries. No major reports have indicated problems directly caused by the IONM procedure itself, making it a promising option for enhancing surgical safety.12345

Why are researchers excited about this trial?

Researchers are excited about the trial using Intraoperative Neuromonitoring (IONM) for breast cancer surgery because it offers a novel approach to enhancing surgical safety. Unlike standard care options, which don't typically involve real-time nerve monitoring, IONM continuously tracks the function of specific nerves, like the median and ulnar nerves, during surgery. This method aims to prevent nerve damage by providing immediate feedback to surgeons, allowing for adjustments to be made on the spot. Additionally, this trial is breaking new ground by attempting to monitor the intercostobrachial and medial brachial cutaneous nerves, which have never been monitored before. The hope is that this could lead to fewer complications and improved recovery for patients undergoing breast cancer surgery.

What evidence suggests that intraoperative neuromonitoring is effective for breast cancer surgery?

Research has shown that intraoperative neuromonitoring (IONM) can enhance surgical safety by helping surgeons avoid damaging critical nerves. This trial will examine the use of IONM during breast cancer surgery, specifically during axillary lymph node dissection (ALND), to determine if it can reduce postoperative pain. Techniques from other nerve monitoring have successfully identified and protected nerves, suggesting similar benefits might occur in breast cancer surgery. The goal is to detect nerve issues early during surgery, potentially lowering the risk of nerve-related pain afterward. Early studies in other surgeries have shown promising results, indicating that IONM might improve outcomes by protecting nerve function.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with confirmed breast cancer who are scheduled to have axillary lymph node dissection (ALND) by a participating surgeon. People with nerve problems, previous major axillary surgery, certain medications, or other serious health issues cannot join.

Inclusion Criteria

I am between 18 and 70 years old.
I have a confirmed diagnosis of breast cancer.
I am having lymph node surgery with a study breast surgeon.

Exclusion Criteria

Patients with demyelinating disease
I have not had any axillary surgery except a needle biopsy or sentinel node biopsy.
I have a neurological condition that affects my nerves, like neuropathy or nerve pain.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo axillary lymph node dissection (ALND) with intraoperative neuromonitoring (IONM) and bipolar electrocautery (BE) to identify and protect nerves

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, focusing on nerve function and post-surgical pain

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • IONM procedure

Trial Overview

The study tests if using intraoperative neuromonitoring (IONM) and bipolar electrocautery during ALND can help surgeons better identify nerves and possibly reduce nerve pain after surgery. These methods are compared to standard surgical techniques.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: IONM during ALND Breast SurgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

Medsurant Health/Evokes Neuromonitoring

Collaborator

Citations

Factors Impacting the Accuracy of Intra-operative Evaluation of ...

The accuracy of intraoperative SLN evaluation for breast cancer is affected by primary tumor histology and size of the SLN metastasis.

Intra-operative assessment of sentinel lymph nodes for ...

This article reviews the techniques available and under development for intraoperative detection of sentinel LN metastasis in BC surgery.

From Axillary Lymph Node Dissection to Sentinel ...

Results. A marked decline in axillary lymph node dissection (ALND) was observed—from 47.9% in 2000–2004 to 18.1% in 2017–2022—with a parallel increase in ...

The intraoperative assessment of sentinel nodes

In our opinion, intraoperative assessment of axillary lymph nodes should be reserved for patients who still have a strict indication for ALND.

Effect of Axillary Dissection vs No ...

A population-based study of the effects of a regional guideline for completion axillary lymph node dissection on axillary surgery in patients with breast cancer ...

Long-Term Study Finds Axillary Radiotherapy Safe and ...

Our new 10-year data show that axillary radiotherapy and axillary lymph node dissection provide excellent and comparable overall survival.

The Role of Axillary Lymph Node Dissection in Breast Cancer ...

While the safety of omitting ALND in the event of positive sentinel lymph nodes has been demonstrated with upfront surgery, data in the post-NAC ...

Feasibility and safety of targeted axillary dissection guided ...

This study confirms the feasibility, safety and accuracy of IOUS guided surgery for axillary staging after NST in node positive BC patients.

Axillary Lymph Node Dissection After Mastectomy Among ...

This study suggests that a substantial proportion of patients with breast cancer with 1 to 2 positive lymph nodes who received a mastectomy underwent treatment ...

Omission of Axillary Lymph Node Dissection in Breast ...

Recent studies suggest that some patients with limited lymph node involvement may safely avoid this more extensive surgery. In this multicenter study of Chinese ...