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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539227
First received: October 2, 2007
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Procedure: NAC Sparing Mastectomy
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539227     History of Changes
Other Study ID Numbers: 2007-0194
Study First Received: October 2, 2007
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013