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Nerve grafting may bring back nipple feeling after breast cancer surgery

NCT ID NCT06153836

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This study looks at whether a nerve graft during nipple-sparing mastectomy can help restore feeling in the nipple. About 20 women with early-stage breast cancer will be randomly assigned to receive the nerve graft or not. The goal is to see if the procedure improves sensation and quality of life.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

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

Started

Dec 2023

Expected to finish

Nov 2026

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 years and older

Sex

Female participants only

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: * Female patients age \>= 18 * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Planned nipple sparing mastectomy (NSM) * Ideal NSM candidates would meet the following criteria: * Cup size A-C * BMI \<34 * Ptosis grade \< 2 * Clinical stage 0 - T2N0 * Final planned implant volume \< 400cc * Inframammary or lateral mammary incision * Tumor \> 0.5cm from the nipple areolar complex (NAC) * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM * No prior breast radiation on side of planned NSM * Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement) * No planned post mastectomy radiation (PMRT) * No nicotine use within 4 weeks of surgical date Exclusion Criteria: * Planned autologous reconstruction (immediate or delayed) * Pregnancy

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma in situ

As listed by the trial registrant

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

Anatomic stage 0 breast cancer ajcc V8 Anatomic stage I breast cancer ajcc V8 Anatomic stage IIA breast cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

    Contact Email: •••••@•••••

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