Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients undergo standard of care NSM on study.

Patients undergo neurotization during standard of care NSM on study.

Neurotization Procedure

Questionnaire Administration

Subcutaneous Mastectomy

Clinical Trials Referral Office

James W. Jakub, M.D.

Olivia S. Ho, M.D., M.S.

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.

Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction

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.

Measured using the BREAST- Q (copyright) scored on a 5-point Likert scale. Results will be reported descriptively.

Measured using the BREAST- Q scored on a 5-point Likert scale. Results will be reported descriptively.

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. Results will be reported descriptively.

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. Results will be reported descriptively.

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.

AEs, using National Cancer Institute Common Terminology Criteria for Adverse Events, will be summarized within arms by reporting the number and percentage of patients. 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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction	NCT06153836	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ...	Neurotization P... Questionnaire A... Subcutaneous Ma...	18 Years -	Mayo Clinic
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction	NCT06153836	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ...	Neurotization P... Questionnaire A... Subcutaneous Ma...	18 Years -	Mayo Clinic

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