Trial Summary
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 have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the treatment called Neurotization Procedure, Subcutaneous Mastectomy effective for restoring sensation after mastectomy in breast cancer patients?Yes, the treatment is promising. It helps restore sensation in the breast after mastectomy by preserving and reconnecting nerves. Studies show that most patients experience improved or preserved sensation, making it a safe and effective option for sensory recovery.7891011
What safety data is available for nerve grafting to restore sensation after mastectomy?Nerve grafting in conjunction with nipple-sparing mastectomy (NSM) and implant-based breast reconstruction has been shown to be safe and effective. In a study involving 16 women (31 breasts), 90% of the cases preserved sensation, with no reports of dysesthesias or neuromas. The procedure involves careful nerve preservation and allografting, which has resulted in intact sensation to light touch in the majority of reconstructed breasts. Common complications of NSM, such as nipple-areolar complex (NAC) ischemia and necrosis, are noted, but techniques like sharp dissection have been reported to mitigate these risks.24567
What data supports the idea that Nerve Grafting for Sensation Restoration After Mastectomy in Breast Cancer is an effective treatment?The available research shows that nerve grafting during nipple-sparing mastectomy and breast reconstruction is effective in preserving sensation. In one study, 90% of patients maintained sensation in their reconstructed breasts, with some even experiencing improved sensation. Another study found that re-innervation of the nipple-areolar complex during immediate breast reconstruction helped enhance sensation recovery. These findings suggest that nerve grafting can be a successful approach to restoring feeling after mastectomy.13789
Eligibility Criteria
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
I am a woman over 18 planning to have nipple-sparing mastectomy.
My eyelid droop is mild or moderate.
I can take care of myself and am up and about more than half of my waking hours.
My cancer is in an early stage and has not spread to lymph nodes.
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.
My tumor is very close to the nipple area.
My surgery involves a breast splitting incision.
I have had radiation on the same side as my planned nipple-sparing mastectomy.
I plan to have breast reconstruction using my own tissue.
My cancer has spread to my lymph nodes.
I had breast cancer before on the same side as my planned nipple-sparing mastectomy.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ARM II (neurotization)Experimental Treatment3 Interventions
Patients undergo neurotization during standard of care NSM on study.
Group II: ARM I (control)Active Control2 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo Clinic in FloridaJacksonville, FL
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
When mastectomy becomes inevitable: the nipple-sparing approach. [2019]The preservation of the nipple areola complex (NAC) could improve the quality of life in cases of mastectomy. A novel radiosurgical treatment combining subcutaneous mastectomy with intraoperative radiotherapy is proposed. Three hundred nipple-sparing mastectomies (NSM) were performed. Invasive (58%) and in situ (42%) carcinomas were included. Clinical complications, aesthetic results, oncological and psychological results were recorded. The NAC necrosed totally in 10 cases and partially in 29 and it was removed in 12. Nine infections (3%) were observed and 10 prostheses removed. Good results were rated by 82.3% of the patients and by 84.8% of the surgeons. In 7.5% a radiodystrophy was observed. The sensitivity of the NAC recovered partially in 48%. Two local recurrences occurred outside the radiated field. Overall, we observed three metastases and no deaths. Sixty-eight of the patients were satisfied with their reconstructed breast and 85.5% were satisfied having preserved the NAC.
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]Prophylactic skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) both are associated with major risk reduction in women with high breast cancer risk. Skin-sparing mastectomy followed by nipple-areola complex (NAC) reconstruction is standard of care, but NSM is increasingly being performed. Preservation of the NAC in NSM may increase patient satisfaction. Therefore, we measured NAC sensitivity after NSM and compared patient satisfaction as well as body image after SSM with NSM.
Delay techniques for nipple-sparing mastectomy: A systematic review. [2018]Rare but serious complications of nipple-sparing mastectomy (NSM) include necrosis of the nipple-areolar complex (NAC) and mastectomy skin flaps. NAC and mastectomy flap delay procedures are novel techniques designed to avoid these complications and may be combined with retroareolar biopsy as a first-stage procedure. We performed a systematic review of the literature to evaluate various techniques for NAC and mastectomy flap delay.
Nipple-areolar complex ischemia and necrosis in nipple-sparing mastectomy. [2019]Nipple-sparing mastectomy (NSM), combined with immediate breast reconstruction, has become the preferred surgical option to achieve better patient satisfaction and aesthetic outcome. However, nipple-areolar complex (NAC) ischemia and necrosis are common complications following nipple-sparing technique.
Nipple-Areola Complex Sensation after Nipple-sparing Mastectomy. [2022]Nipple-sparing mastectomy (NSM) has been proven to be oncologically safe for treating breast cancer. This procedure had been developed to optimize the esthetic outcome and reduce feeling mutilation after mastectomy. Risks of necrotic complications and diminishing nipple-areola complex (NAC) sensation are common complications affecting the patient's satisfaction after the surgery. The evaluation of NAC sensation should be also investigated.
The Role of Sharp Dissection in Nipple-Sparing Mastectomy: A Safe Procedure with No Necrosis of the Nipple-Areolar Complex. [2022]Nipple-sparing mastectomy (NSM) is becoming increasingly accepted as a treatment for breast disease; however, nipple-areolar complex (NAC) necrosis, a frequent severe postoperative complication, inhibits the popularity of this procedure. This study reports the technical aspects and short-term postoperative outcomes of NSM.
Nerve Preservation and Allografting for Sensory Innervation Following Immediate Implant Breast Reconstruction. [2020]While newer breast reconstruction approaches utilizing nipple-sparing mastectomy (NSM) techniques and immediate reconstruction can provide excellent aesthetic outcomes, absent postoperative sensation remains a major limitation. Here, we present a novel technique for implant reconstruction combining the latest advances in breast oncologic, reconstructive, and peripheral nerve surgery to improve sensory outcomes. Sixteen women (31 breasts) underwent NSM and prepectoral, direct-to-implant reconstruction. During NSM, careful dissection was performed along the lateral aspect of the breast to preserve any visible intercostal nerves. When nerves could be preserved without compromising oncologic safety, they were left intact within the subcutaneous tissue of the lateral mastectomy skin flap. Nipple/areolar complex (NAC) neurotization was also performed utilizing allograft coapted from transected T4 or T5 lateral intercostal nerves to subareolar nerves identified at the completion of the mastectomy. Of the 12 women (23 breasts) with at least 3 months' follow-up, NAC 2-point discrimination was preserved in 20 breasts (87%), was worse in 2 breasts (9%), and had actually improved in 1 breast (4%). All patients had intact sensation to light touch throughout the majority of, if not their entire, reconstructed breasts. None of the women developed dysesthesias or neuromas. Nerve grafting in conjunction with careful nerve preservation at the time of NSM and implant-based breast reconstruction is safe and effective with a 90% rate of preserved sensation. With longer follow-up, continued return of sensation or possibly improved sensation from baseline can be reasonably anticipated.
Immediate Targeted Nipple-Areolar Complex Reinnervation: Improving Outcomes in Gender-affirming Mastectomy. [2022]Female-to-male mastectomy often renders the chest skin and nipple-areolar complex (NAC) insensate. We propose a new technique of preserving the intercostal nerves and using them to reinnervate the NAC after mastectomy.
Immediate targeted nipple-areolar complex re-innervation: Improving outcomes in immediate autologous breast reconstruction. [2021]Breast reconstruction often renders the chest skin and nipple areolar complex (NAC) insensate. We propose a new technique of preserving the intercostal nerves during mastectomy and using them to reinnervate the NAC following mastectomy and immediate autologous tissue reconstruction. The technique involves preservation of the lateral intercostal nerves during mastectomy, dissection of the lateral intercostal nerves to length, coaptation of the intercostal nerves to a nerve graft which is then tunneled through the free flap and the distal nerve graft is then coapted to the nerve stumps at the base of the NAC. We performed a retrospective analysis of 14 breasts, which underwent nipple reinnervation during immediate autologous breast reconstruction. Mean age was 49 years (range: 32-61 years). Sensory outcomes, as tested with Semmes-Weinstein monofilaments, were compared to a cohort of breasts that underwent nipple sparing mastectomy without neurotization. Compared to control patients, there was no statistically significant difference (p = 0.0969) in sensation between pre-operative and post-operative nipple sensation at final follow-up. This proof-of-concept study suggests that immediate re-innervation of the NAC in the setting of immediate breast reconstruction enhances recovery of the NAC sensation.
Post-mastectomy sensory recovery and restoration. [2021]Breast sensation has recently become an integral aspect of the reconstructive goal after mastectomy and is an important consideration for many patients. Neurotization techniques using primary coaptation, autograft, allograft, or nerve conduit have been used for autologous flaps, such as the deep inferior epigastric perforator (DIEP) flap. Outcomes have shown improved sensation and faster sensory recovery in the flap skin in immediate neurotized DIEP flap breast reconstructions compared to delayed reconstruction. Breast flap neurotization during reconstruction is a rapid and simple procedure with minimal morbidity. An improved understanding of breast anatomy and innovative modifications to breast reconstruction have made the restoration of breast sensation achievable, and promising results have been obtained with respect to sensory return and patient satisfaction.
Modern Approaches to Breast Neurotization. [2023]Absent or diminished breast sensation is a persistent problem for many postmastectomy patients. Breast neurotization is an opportunity to improve sensory outcomes, which are poor and unpredictable if left to chance. Several techniques for autologous and implant reconstruction have been described with successful clinical and patient-reported outcomes. Neurotization is a safe procedure with minimal risk for morbidity and it presents a fantastic avenue for future research.