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

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ClinicalTrials.gov Identifier: NCT00539227
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: NAC Sparing Mastectomy Behavioral: Questionnaire

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
Study Start Date : October 2007
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Group/Cohort Intervention/treatment
NAC Sparing Mastectomy
A skin-sparing mastectomy performed with preservation of the nipple-areolar complex (NAC). Questionnaires taking about 20-30 minutes to complete.
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.
Other Name: Survey



Primary Outcome Measures :
  1. Nipple Sensation Evaluation (following NAC sparing mastectomy) [ Time Frame: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breast cancer.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539227


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gildy V. Babiera, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539227     History of Changes
Other Study ID Numbers: 2007-0194
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Nipple-Areolar Complex
Mastectomy
Prophylactic mastectomy
Immediate reconstruction
Reconstructive surgery
Questionnaire
Survey
NAC