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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09574 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-004411 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC230302 | Other Identifier | Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (control) | Active Comparator | Patients undergo standard of care NSM on study. |
|
| ARM II (neurotization) | Experimental | Patients undergo neurotization during standard of care NSM on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurotization Procedure | Procedure | Undergo placement of nerve graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and up to 12 months |
| Psychosocial well-being |
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Inclusion Criteria:
Female patients age >= 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Planned nipple sparing mastectomy (NSM)
Ideal NSM candidates would meet the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| James W. Jakub, M.D. | Mayo Clinic | Principal Investigator |
| Olivia S. Ho, M.D., M.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Subcutaneous Mastectomy | Procedure | Undergo standard of care NSM |
|
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | At 12 months |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015414 | Mastectomy, Subcutaneous |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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