A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Breast Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539227
• Other study ID #: 2007-0194
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: August 23, 2013
• Start date: October 2007
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.

Description:

Operative Procedure:

You will have a skin-sparing mastectomy performed with preservation of the NAC. During surgery, the tissue will be tested while you are still under general anesthesia.

The NAC may be removed completely during the surgery if malignant cells are found during the testing done during the surgery or if suspicious cells that are not clearly benign cells are found. This will be up to your doctor. The NAC may also be removed surgically if the primary tumor is found to be located less than an inch from the border of the NAC, or you are found to have breast cancer with multiple "center" sites. The nipple can also be removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if your doctor is worried about its blood supply. These decisions will be made by your pathologist and treating surgeon.

You will then undergo immediate reconstruction, with either your own tissue, prosthetic tissue, or a combination of the two. This is up to your plastic surgeon. You will have met with your plastic surgeon before surgery to discuss the best reconstructive method for you, and you will be given an informed consent to sign at that time with details about the method you decide to use.

The breast tissue under the NAC will be biopsied and tested after your surgery. After that tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC removed in a separate operation. The place where the NAC was removed will be repaired by a plastic surgeon, who will choose the best method to get an acceptable cosmetic result. This may involve one or more extra surgeries, and you will be given separate informed consent documents to sign for each surgery.

Follow-up and Questionnaires:

If you agree to take part in this study, 4 sensory tests will be conducted on both breasts using a variety of hand-held devices. These tests are painless and will be performed at regularly scheduled follow-up visits in clinic. They will measure nipple and areolar sensitivity, as well as nipple erectibility. The tests will involve the placement of fibers of various thicknesses and blunt metal probes on the skin of your nipple and areola. All tests will be performed once before the surgery and then at about 3 months, 6 months, and 1 year after surgery, at your follow-up clinic visits.

Your breasts will be photographed at your 6-month and 1-year follow-up visits after surgery. At these visits, you will look at those photographs to decide how satisfied you are with how the breasts look. Two (2) plastic surgeons not directly involved in your surgery will also study those photographs by themselves and fill out a similar questionnaire rating their impression of the results of your plastic surgery. These results will not be made available to you. You will also complete 2 quality-of-life questionnaires within 1 month of your surgery, and then at 3 months, 6 months, 1 year, 2 years, and 5 years after surgery (+/- 1 month). The questionnaires will ask questions about nipple sensation, cosmetic outcomes, complications, and your quality of life. The questionnaires will take about 30 minutes to complete.

Length of Study:

You will remain on study for up to 5 years.

This is an investigational study. Up to 37 patients will take part in this study. All will be enrolled at MD Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients desiring prophylactic mastectomy with immediate reconstruction

2. Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction

3. Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam

4. Patients must sign an informed consent and be registered before the procedure is performed

Exclusion Criteria:

1. Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge

2. Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of the NAC

3. Patients with Paget's disease of the nipple

4. Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin

5. Patients with history of prior surgery involving a periareolar incision

6. Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy

7. Patients with macromastia as defined by the plastic surgeon

8. Patients with a body mass index (BMI) greater than 40 kg/m2

9. Patients who actively smoke

10. Patients with known collagen vascular disease

11. Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• NAC Sparing Mastectomy
A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC).

Behavioral:
• Questionnaire
Questionnaires taking about 20-30 minutes to complete.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple Sensation Evaluation (following NAC sparing mastectomy)		Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)	No

External Links

•   The University of Texas (UT) MD Anderson Cancer Center official website