What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as surgery (including nipple-sparing mastectomy), radiotherapy, and systemic treatments (chemotherapy, anti-Her2 therapy, and antihormonal treatments), are associated with a range of side effects. Surgery can lead to complications like loss of nipple sensation and scarring. Radiotherapy often results in skin changes, fatigue, and lymphedema. Chemotherapy is known for causing weakness, fatigue, insomnia, chemotherapy-induced peripheral neuropathy (CIPN), and drug-induced arthralgia. Anti-Her2 therapy and antihormonal treatments can also contribute to these side effects, with additional risks of cardiovascular issues and menopausal symptoms, respectively.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of surgical and non-surgical options. Surgical treatments often involve mastectomy or lumpectomy, with nipple-sparing mastectomy being a common choice for preserving the nipple-areolar complex. Non-surgical treatments include chemotherapy agents like paclitaxel and doxorubicin, hormone therapies such as tamoxifen and aromatase inhibitors, and targeted therapies like trastuzumab for HER2-positive breast cancer. While the neurotization of the nipple-areolar complex is a novel surgical technique aimed at restoring sensation post-mastectomy, it is not yet a standard FDA-approved treatment but is being studied for its potential to improve quality of life in breast cancer patients.

What other types of research exist?

Promising alternatives to neurotization of the NAC for restoring sensation in breast cancer patients include: 1) Flap neurotization using processed nerve allografts, which has shown a greater degree of return of protective sensation in reconstructed breasts. 2) Injectable soft tissue fillers, such as hyaluronic acid or calcium hydroxylapatite, which have been used to enhance tissue projection and may aid in sensory restoration. 3) Cognitive behavioral therapy (CBT) and other psychological treatments, which have been effective in managing sensory deficits and improving quality of life in patients with sensory loss.

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Procedure

Nerve Grafting for Sensation Restoration After Mastectomy in Breast Cancer

Phase 2

Recruiting

Led By James W. Jakub, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients age >= 18 undergoing NSM

Ptosis grade =< 2

Must not have

Prior breast reduction, augmentation or mastopexy on side of planned NSM

Prior periareolar incision >= 3.1cm on side of planned NSM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include typical surgical risks such as infection, bleeding, scarring; specific to neurotization could be altered sensation or numbness around the operated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My eyelid droop is mild or moderate.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My cancer is in an early stage and has not spread to lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I am scheduled for radiation therapy after breast removal surgery.

Select...

My tumor is very close to the nipple area.

Select...

My surgery involves a breast splitting incision.

Select...

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

Select...

I plan to have breast reconstruction using my own tissue.

Select...

My cancer has spread to my lymph nodes.

Select...

I had breast cancer before on the same side as my planned nipple-sparing mastectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization

Secondary study objectives

Chest physical well-being

Incidence of adverse events (AEs)

Mastectomy skin flap necrosis

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include surgery, chemotherapy, radiation therapy, and targeted therapy. Surgery, such as mastectomy, involves removing the tumor and possibly surrounding tissues. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy employs high-energy rays to destroy cancer cells. Targeted therapy involves drugs that specifically target cancer cell mechanisms, such as hormone receptors or proteins involved in cancer growth. These treatments are essential for effectively managing breast cancer, reducing recurrence, and improving survival rates. For patients undergoing procedures like neurotization to restore nipple sensation post-mastectomy, understanding these treatments helps in making informed decisions and managing side effects, ultimately enhancing their quality of life.

Sensory change of the reconstructed breast envelope after skin-sparing mastectomy.Chronic pain in breast cancer survivors: comparison of psychosocial, surgical, and medical characteristics between survivors with and without pain.