Nipple sensitivity after prophylactic nipple-sparing mastectomy compared to healthy BRCA1/2 gene mutation carriers.

Many women with a BRCA1/2 mutation choose to undergo (bilateral) prophylactic
mastectomy, diminishing breast cancer risk by by 90-100%. Lately there has been
increasing interest for the cosmetic results after such an operation. To allow
for immediate breast reconstruction after prophylactic mastectomy, a
subcutaneous mastectomy is performed to spare the skin envelope of the breast.
It is possible to spare the nipple together with the skin. Long-term safety and
cosmetic results of nipple-sparing mastectomies are unknown. However, some
women choose nipple sparing mastectomy because of the presumed more natural
result of this operation.

The aim of this study is to objectify nipple-areola complex sensitivity in
women who underwent unilateral or bilateral prophylactic NSM in Erasmus
MC-Daniel den Hoed Cancer Center and their satisfaction with this operation,
compared to healthy women who never underwent a breast operation.

Women who underwent uni- or bilateral prophylactic nipple-sparing mastectomy
are asked to participate at least one year after operation.
After obtaining informed consent, sensitivity of the NAC will be tested using
Semmes-Weinstein monofilaments with five increasing diameters. Starting with
the smallest monofilament diameter three short touches are applied to five
different sites of the nipple, and to four sites para-areolar lateral and
medial. If the patient doesn*t respond, monofilament diameters are increased
step by step, until touch is distinguished.
The diameter of the lightest monofilament which can be distinguished is scored.
The mean of all scores is calculated,

Each site will be tested for hot and cold sensations using metal probes at
approximately 10°C and 40°C. If the patient is able to distinguish both
temperatures, she will score 1 point per site.

Additionally, patients are asked to fill out two questionnaire, Hopwood's Body
Image Scale (BIS) and the Dutch Breast-Q (reconstruction module). The 10-point
BIS contains questions about about body image and validation of a Dutch version
is about to be finished. Thirteen complementary questions about nipple
sensitivity and satisfaction with the choice of operation are added. The BIS
and the additional questions are only administered to the operated arm.
The Breast-Q reconstruction module contains questions concerning body image,
satisfaction with the operation and cosmetic results and consists of a
pre-operative and a post-operative part. The pre-operative questions will be
administered to the control arm, the post-operative questions will be
administered to the group that underwent a nipple-sparing mastectomy.

The study burden is very low. No invasive interventions are done and the unique
outpatient clinic visit takes only about 15 minutes.
Some questions in the questionnaire concern private matters.
There are no risks for the tested subjects.