Clinical trial NCT01002014: Nipple Sparing Mastectomy - Cosmetic Outcomes
Official title: Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast Reconstruction
Cosmesis
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The 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.

Eligibility 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

Primary outcomes:
measure: Cosmetic Appearance
timeFrame: First Post Operative year
measure: Patient Satisfaction
timeFrame: First Post Operative Year
measure: Presence of tumor in nipple areolar complex frozen section
timeFrame: Duration of Study
measure: Presence of tumor in nipple areolar complex permanent histology
timeFrame: Duration of study
Secondary outcomes:
measure: Complications
timeFrame: First Post Operative year
measure: Local Recurrence
timeFrame: One year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Carolinas Healthcare
name: Richard L White, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vlajcic Z, Zic R, Stanec S, Lambasa S, Petrovecki M, Stanec Z. Nipple-areola complex preservation: predictive factors of neoplastic nipple-areola complex invasion. Ann Plast Surg. 2005 Sep;55(3):240-4. doi: 10.1097/01.sap.0000171680.49971.85.
citation: Crowe JP, Patrick RJ, Yetman RJ, Djohan R. Nipple-sparing mastectomy update: one hundred forty-nine procedures and clinical outcomes. Arch Surg. 2008 Nov;143(11):1106-10; discussion 1110. doi: 10.1001/archsurg.143.11.1106.
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citation: Stolier AJ, Sullivan SK, Dellacroce FJ. Technical considerations in nipple-sparing mastectomy: 82 consecutive cases without necrosis. Ann Surg Oncol. 2008 May;15(5):1341-7. doi: 10.1245/s10434-007-9753-5. Epub 2008 Feb 7.
citation: Wijayanayagam A, Kumar AS, Foster RD, Esserman LJ. Optimizing the total skin-sparing mastectomy. Arch Surg. 2008 Jan;143(1):38-45; discussion 45. doi: 10.1001/archsurg.143.1.38.
citation: Banerjee A, Gupta S, Bhattacharya N. Preservation of nipple-areola complex in breast cancer--a clinicopathological assessment. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):1195-8. doi: 10.1016/j.bjps.2007.08.005. Epub 2007 Sep 27.
citation: Loewen MJ, Jennings JA, Sherman SR, Slaikeu J, Ebrom PA, Davis AT, Fitzgerald TL. Mammographic distance as a predictor of nipple-areola complex involvement in breast cancer. Am J Surg. 2008 Mar;195(3):391-4; discussion 394-5. doi: 10.1016/j.amjsurg.2007.12.020.
citation: Laronga C, Kemp B, Johnston D, Robb GL, Singletary SE. The incidence of occult nipple-areola complex involvement in breast cancer patients receiving a skin-sparing mastectomy. Ann Surg Oncol. 1999 Sep;6(6):609-13. doi: 10.1007/s10434-999-0609-z.
citation: Gerber B, Krause A, Reimer T, Muller H, Kuchenmeister I, Makovitzky J, Kundt G, Friese K. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003 Jul;238(1):120-7. doi: 10.1097/01.SLA.0000077922.38307.cd.
citation: Fitzal F. Can nipple-sparing mastectomy and immediate breast reconstruction with modified extended latissimus dorsi muscular flap improve the cosmetic and functional outcome of patients with breast cancer? World J Surg. 2008 Mar;32(3):499; author reply 500-1. doi: 10.1007/s00268-007-9268-z. No abstract available.
citation: Carlson GW, Losken A, Moore B, Thornton J, Elliott M, Bolitho G, Denson DD. Results of immediate breast reconstruction after skin-sparing mastectomy. Ann Plast Surg. 2001 Mar;46(3):222-8. doi: 10.1097/00000637-200103000-00003.
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