Nerve Grafting for Sensation Restoration After Mastectomy in Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Planned autologous reconstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: Immediate (surgical procedure)

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies if patients are willing to join a study comparing standard nipple sparing mastectomy (NSM) with and without a technique aimed at restoring sensation in the nipple area. The goal is to see if this improves quality of life and sensation for patients.

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

The trial information does not specify whether you need to stop taking your current medications.

Is nerve grafting for sensation restoration after mastectomy generally safe?

Nerve grafting during nipple-sparing mastectomy (NSM) and breast reconstruction is generally safe, with studies showing a high rate of preserved sensation and no reports of severe complications like dysesthesias (abnormal sensations) or neuromas (nerve tissue growths). However, common complications of NSM include risks of necrosis (tissue death) and reduced sensation in the nipple-areola complex. ^{1 2 3 4 5}

How is the nerve grafting treatment for sensation restoration after mastectomy different from other treatments?

This treatment is unique because it involves preserving and reconnecting nerves during mastectomy to restore sensation in the breast, specifically targeting the nipple-areolar complex. Unlike traditional methods that often leave the area numb, this approach uses nerve grafts to improve sensory outcomes, making it a novel option for patients seeking to regain feeling after breast reconstruction. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment for sensation restoration after mastectomy?

Research shows that nerve grafting and preservation during nipple-sparing mastectomy can effectively restore sensation, with 90% of patients experiencing preserved or improved sensation in the nipple-areolar complex. This suggests that the treatment is safe and can lead to significant sensory recovery. ^{3 5 6 9 10}

Who Is on the Research Team?

James W Jakub

Principal Investigator

Mayo Clinic

Olivia Ho, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for female breast cancer patients aged 18 or older who are undergoing nipple sparing mastectomy (NSM) with specific criteria: ECOG status of 0-2, A-C cup size, BMI ≤34, ptosis grade ≤2, clinical stage 0-T2N0, and implant volume ≤400cc. Exclusions include prior breast cancer treatments or surgeries on the affected side and active nicotine use.

Inclusion Criteria

My breast surgery incision is under the breast or on the side.

I am a woman over 18 planning to have nipple-sparing mastectomy.

My bra cup size is between A and C.

Exclusion Criteria

I have had breast surgery on the same side as my planned nipple-sparing mastectomy.

I have had a surgery cut around my nipple area longer than 3.1cm.

I am scheduled for radiation therapy after breast removal surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo nipple sparing mastectomy (NSM) with or without neurotization

Immediate (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up visits at 14 days, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Neurotization Procedure
• Subcutaneous Mastectomy

Trial Overview The study tests if adding a neurotization procedure to NSM can restore sensation in the nipple area. It compares patient satisfaction between those who have standard NSM and those who receive additional nerve grafting aimed at improving quality of life and sexual functionality of the breast.

How Is the Trial Designed?

Group I: ARM II (neurotization) Experimental Treatment 3 Interventions

Patients undergo neurotization during standard of care NSM on study.

Group II: ARM I (control) Active Control 2 Interventions

Patients undergo standard of care NSM on study.

Neurotization Procedure is already approved in United States, European Union for the following indications:

Approved in United States as NAC Neurotization for:

• Restoration of nipple sensation after nipple-sparing mastectomy and reconstruction

Approved in European Union as NAC Neurotization for:

• Restoration of nipple sensation after nipple-sparing mastectomy and reconstruction

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A novel technique for breast reconstruction after nipple-sparing mastectomy (NSM) was developed, focusing on preserving intercostal nerves and utilizing nerve grafting, which resulted in an impressive 90% rate of preserved sensation in the reconstructed breasts.

Among the 12 women followed for at least 3 months, 87% maintained normal two-point discrimination at the nipple/areolar complex, and all patients reported intact sensation to light touch, indicating that this approach is both safe and effective for improving sensory outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Preservation and Allografting for Sensory Innervation Following Immediate Implant Breast Reconstruction. Peled, AW., Peled, ZM.[2020]

A new technique for preserving intercostal nerves during mastectomy and using them to reinnervate the nipple areolar complex (NAC) was tested in a study of 14 patients, aged 32 to 61, who underwent immediate autologous breast reconstruction.

The study suggests that this technique may enhance the recovery of sensation in the NAC, although the results did not show a statistically significant difference in sensation compared to a control group that did not receive neurotization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate targeted nipple-areolar complex re-innervation: Improving outcomes in immediate autologous breast reconstruction. Tevlin, R., Brazio, P., Tran, N., et al.[2021]

A new technique for female-to-male mastectomy that preserves and reinnervates the intercostal nerves significantly improves sensation in the nipple-areolar complex (NAC) compared to traditional mastectomy methods, as shown in a study of 10 patients aged 16-19.

Patients who underwent the nerve-sparing technique experienced significant improvements in sensation at the nipple, areola, and surrounding skin, with no loss of sensation compared to preoperative levels, suggesting this method could enhance recovery in similar surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Targeted Nipple-Areolar Complex Reinnervation: Improving Outcomes in Gender-affirming Mastectomy. Rochlin, DH., Brazio, P., Wapnir, I., et al.[2022]

Delay procedures for nipple-sparing mastectomy (NSM) have a good safety profile, with only 8.9% of patients experiencing partial nipple-areolar complex necrosis and 7.9% experiencing mastectomy flap necrosis among 101 patients studied.

These procedures not only reduce the risk of complications but also allow for retroareolar biopsies to be performed, which can help in planning the surgical approach and reducing the chances of false-negative results during the mastectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delay techniques for nipple-sparing mastectomy: A systematic review. Karian, LS., Therattil, PJ., Wey, PD., et al.[2018]

Nipple-sparing mastectomy (NSM) is a safe and effective surgical option for breast cancer treatment, with a low rate of nipple-areola complex (NAC) removal and a median follow-up of 24 months showing only 3 locoregional recurrences among 55 procedures.

Approximately 44% of patients experienced partial recovery of NAC sensation within 6 months post-surgery, indicating that some patients can retain sensation after the procedure, although complete recovery is rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple-Areola Complex Sensation after Nipple-sparing Mastectomy. Chirappapha, P., Srichan, P., Lertsithichai, P., et al.[2022]

In a study of 110 patients undergoing nipple-sparing mastectomy (NSM), no cases of nipple-areolar complex (NAC) necrosis were reported, indicating a high safety profile for this surgical technique.

The use of a specific surgical method involving sharp dissection and careful flap management resulted in only minor complications, such as temporary discoloration or ischemia in six nipples, with all NACs remaining intact after an average follow-up of 30 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Sharp Dissection in Nipple-Sparing Mastectomy: A Safe Procedure with No Necrosis of the Nipple-Areolar Complex. Yang, CQ., Ji, F., Gao, HF., et al.[2022]

Women who underwent skin-sparing mastectomy (SSM) reported higher satisfaction with their breasts and overall outcomes compared to those who had nipple-sparing mastectomy (NSM), suggesting SSM may be a more favorable option for patients.

Nipple-areola complex (NAC) sensitivity was significantly lower in the NSM group compared to a non-operated control group, indicating that while NSM preserves the NAC, it may result in reduced sensitivity post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction and Nipple-Areola Sensitivity After Bilateral Prophylactic Mastectomy and Immediate Implant Breast Reconstruction in a High Breast Cancer Risk Population: Nipple-Sparing Mastectomy Versus Skin-Sparing Mastectomy. van Verschuer, VM., Mureau, MA., Gopie, JP., et al.[2017]

In a study of 220 breasts undergoing nipple-sparing mastectomy (NSM) with immediate reconstruction, 64.1% experienced nipple-areolar complex (NAC) ischemia, but only 31.3% required surgical reoperation due to necrosis, indicating a high rate of ischemia but relatively low rates of severe complications.

Factors such as the presence of breast ptosis and the type of surgical incision significantly influenced the risk of NAC necrosis, with lower periareolar incisions being safer for preserving NAC vascularity compared to upper incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple-areolar complex ischemia and necrosis in nipple-sparing mastectomy. Ahn, SJ., Woo, TY., Lee, DW., et al.[2019]

Breast neurotization can significantly improve sensory outcomes for postmastectomy patients, addressing the common issue of absent or diminished breast sensation.

The procedure is considered safe with minimal risk of complications, making it a promising area for further research in enhancing patient recovery and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modern Approaches to Breast Neurotization. O'Neill, RC., Spiegel, AJ.[2023]

Neurotization techniques used during immediate DIEP flap breast reconstructions significantly improve breast sensation and sensory recovery compared to delayed reconstructions, highlighting their efficacy in enhancing patient outcomes.

The procedure is described as rapid and simple with minimal morbidity, making it a promising option for restoring breast sensation and increasing patient satisfaction after mastectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-mastectomy sensory recovery and restoration. Hamilton, KL., Kania, KE., Spiegel, AJ.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Nerve Preservation and Allografting for Sensory Innervation Following Immediate Implant Breast Reconstruction. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate targeted nipple-areolar complex re-innervation: Improving outcomes in immediate autologous breast reconstruction. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Immediate Targeted Nipple-Areolar Complex Reinnervation: Improving Outcomes in Gender-affirming Mastectomy. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Delay techniques for nipple-sparing mastectomy: A systematic review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Nipple-Areola Complex Sensation after Nipple-sparing Mastectomy. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The Role of Sharp Dissection in Nipple-Sparing Mastectomy: A Safe Procedure with No Necrosis of the Nipple-Areolar Complex. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient Satisfaction and Nipple-Areola Sensitivity After Bilateral Prophylactic Mastectomy and Immediate Implant Breast Reconstruction in a High Breast Cancer Risk Population: Nipple-Sparing Mastectomy Versus Skin-Sparing Mastectomy. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Nipple-areolar complex ischemia and necrosis in nipple-sparing mastectomy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Modern Approaches to Breast Neurotization. [2023]

10. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Post-mastectomy sensory recovery and restoration. [2021]