This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.
PRIMARY OBJECTIVE: I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization. SECONDARY OBJECTIVES: I. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization. II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization. III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo standard of care NSM on study. ARM II: Patients undergo neurotization during standard of care NSM on study. After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Undergo placement of nerve graft
Ancillary studies
Undergo standard of care NSM
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGPercentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization
Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.
Time frame: Up to 2 years
Chest physical well-being
Measured using the BREAST-Q© scored on a 3-point Likert scale where 1=None of the time and 3=All of the time. Higher scores indicate poorer chest physical well-being.
Time frame: At baseline and up to 12 months
Psychosocial well-being
Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer psychosocial well-being.
Time frame: At baseline and up to 12 months
Sexual well-being
Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer sexual well-being.
Time frame: At baseline and up to 12 months
Patient reported amount of sensation in nipple areolar complex (NAC) and breast
Patient reported amount of sensation in nipple areolar complex (NAC) and breast will be will be assessed using a 5-item sensation questionnaire with 5 options to answer each question. Examples of answers include a range from Very unpleasant to Very pleasant or Unimportant to Very Important. Results will be reported descriptively.
Time frame: At baseline and up to 12 months
Patient reported significance of breast or NAC for sexuality
Patient reported significance of breast or NAC for sexuality will be assessed using a 5-item Significance of Breast or Nipple Areolar Complex for Sexuality Questionnaire with 5 options to answer each question: Not at all, A little bit, Somewhat, Quite a bit, or Very much. Results will be reported descriptively.
Time frame: At baseline and up to 12 months
Tactile sensitivity scores
Measured using Semmes Weinstein monofilament test. Scores will be averaged for each patient across all breast/ NAC measurements and summarized in terms of mean, standard deviation, median, and range. The ordinal score at each of the sites will also be summarized in terms of median and range. Frequency and type of missing data will be summarized.
Time frame: At baseline and up to 12 months
Incidence of adverse events (AEs)
AEs will be scored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and will be summarized within arms by reporting the number and percentage of patients for each AE. The maximum grade for each type of AEs will be recorded for each patient and frequency tables will be reviewed to determine overall patterns. The frequency and type of solicited AEs experienced in each arm will also be reported.
Time frame: At 12 months
Mastectomy skin flap necrosis
Incidence of mastectomy skin flap necrosis will be assessed using the skin ischemia necrosis (SKIN) score, as recorded by clinical staff. Necrosis is defined as any depth SKIN score of C or D and surface area \>1.
Time frame: At 12 months
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