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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00539227 |
Purpose
Primary Objectives:
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: NAC Sparing Mastectomy Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| NAC Sparing Mastectomy |
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.
|
Operative Procedure:
You will have a skin-sparing mastectomy performed with preservation of the nipple-areolar complex (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 a quality-of-life questionnaire 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 questionnaire will ask questions about nipple sensation, cosmetic outcomes, complications, and your quality of life. The questionnaire will take about 20-30 minutes to complete.
Length of Study:
You will remain on study for up to 5 years.
This is an investigational study. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with breast cancer.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Gildy V. Babiera, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Gildy V. Babiera, MD/Associate Professor ) |
| Study ID Numbers: | 2007-0194 |
| Study First Received: | October 2, 2007 |
| Last Updated: | January 26, 2010 |
| ClinicalTrials.gov Identifier: | NCT00539227 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Nipple-Areolar Complex Mastectomy Prophylactic mastectomy Immediate reconstruction |
Reconstructive surgery Questionnaire Survey NAC |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |