Nipple Sparing Mastectomy - Cosmetic Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Richard White, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01002014
First received: October 26, 2009
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex. These outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.


Condition Intervention
Breast Cancer
Breast Reconstruction
Cosmesis
Procedure: Nipple Sparing Mastectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Cosmetic Appearance [ Time Frame: First Post Operative year ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: First Post Operative Year ] [ Designated as safety issue: No ]
  • Presence of tumor in nipple areolar complex frozen section [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
  • Presence of tumor in nipple areolar complex permanent histology [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications [ Time Frame: First Post Operative year ] [ Designated as safety issue: No ]
  • Local Recurrence [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: January 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nipple Sparing Mastectomy
Patients who undergo nipple sparing mastectomy with preservation of the nipple areolar complex.
Procedure: Nipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requiring mastectomy for cancer and/or prophylaxis
  • Age greater than or equal to 18 at time of surgery
  • BMI less than or equal to 35
  • If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

Exclusion Criteria:

  • Currently smoking
  • Prior radiation to the affected breast
  • Systemic lupus erythematosus
  • Central tumor location and/or tumor within 2 cm of NAC
  • Paget's disease of the nipple
  • Clinical evidence of tumor involvement in the nipple
  • Clinical evidence of axillary nodal tumor involvement
  • Lymphovascular invasion of the tumor on core biopsy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002014

Contacts
Contact: Richard L White, MD 980-442-2000 richard.white@carolinashealthcare.org
Contact: Susan Postell, RN 980-442-2000 susan.postell@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center - Blumenthal Cancer Center Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Richard L White, MD         
Sub-Investigator: Terry Sarantou, MD         
Sub-Investigator: Teresa Flippo, MD         
Sub-Investigator: Karinn Chambers, MD         
Sub-Investigator: Mindy Merritt, MD         
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Richard L White, MD Carolinas Healthcare
  More Information

Publications:

Responsible Party: Richard White, Chief, Division of Surgical Oncology, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01002014     History of Changes
Other Study ID Numbers: 01-09-15B
Study First Received: October 26, 2009
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Breast Cancer
Skin Sparing Mastectomy
Breast Cancer Prophylaxis
Nipple Sparing Mastectomy
Nipple Areolar Complex
Mastectomy
Breast Reconstruction
Local recurrence following nipple sparing mastectomy
Cosmetic outcomes following nipple sparing mastectomy
Complications following nipple sparing mastectomy

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

ClinicalTrials.gov processed this record on October 23, 2014