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New Nerve-Saving technique could reduce chronic pain after breast cancer surgery

NCT ID NCT07528638

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether using nerve monitoring tools during breast cancer lymph node removal can help surgeons identify and protect nerves that often cause long-term pain. Six women with breast cancer will have the procedure, and researchers will check if the nerve signals can be reliably tracked. If it works, this approach might reduce the risk of chronic nerve pain after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a standard technique to reduce chronic nerve pain after breast cancer surgery.
What could go wrong
This is a very small, early feasibility study with only 6 participants, so results may not apply to everyone. It tests a procedure, not a treatment, so direct patient benefit is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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