[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06153836":3,"trial-entities:NCT06153836":141,"trial-summary:NCT06153836":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":50,"secondary_outcomes":55,"sex":82,"minimum_age":83,"maximum_age":84,"healthy_volunteers":15,"eligibility_criteria":85,"std_ages":107,"locations":110,"central_contacts":131,"overall_officials":133,"references":136,"see_also_links":137},"NCT06153836","MC230302","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","RECRUITING","2026-11-10","2026-08","2026-08-19","2023-12-05","Mayo Clinic","OTHER",false,"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:\n\nI. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.\n\nSECONDARY OBJECTIVES:\n\nI. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.\n\nII. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.\n\nIII To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo standard of care NSM on study.\n\nARM II: Patients undergo neurotization during standard of care NSM on study.\n\nAfter completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.",[19,20,21],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},45,"ESTIMATED",[31,39,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"PROCEDURE","Neurotization Procedure","Undergo placement of nerve graft",[36],"ARM II (neurotization)",[38],"Nerve Regeneration Procedure",{"type":14,"name":40,"description":41,"armGroupLabels":42},"Questionnaire Administration","Ancillary studies",[43,36],"ARM I (control)",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Subcutaneous Mastectomy","Undergo standard of care NSM",[43,36],[49],"Nipple-Sparing Mastectomy",[51],{"measure":52,"description":53,"timeFrame":54},"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",[56,60,63,66,69,72,75,79],{"measure":57,"description":58,"timeFrame":59},"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",{"measure":61,"description":62,"timeFrame":59},"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.",{"measure":64,"description":65,"timeFrame":59},"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.",{"measure":67,"description":68,"timeFrame":59},"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.",{"measure":70,"description":71,"timeFrame":59},"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.",{"measure":73,"description":74,"timeFrame":59},"Tactile sensitivity scores","Measured using Semmes Weinstein monofilament test. Scores will be averaged for each patient across all breast\u002F 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.",{"measure":76,"description":77,"timeFrame":78},"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",{"measure":80,"description":81,"timeFrame":78},"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.","FEMALE","18 Years",null,{"inclusion":86,"exclusion":103,"raw_text":106},[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"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:","Cup size A-C","BMI \\\u003C34","Ptosis grade \\\u003C 2","Clinical stage 0 - T2N0","Final planned implant volume \\\u003C 400cc","Inframammary or lateral mammary incision","Tumor \\> 0.5cm from the nipple areolar complex (NAC)","No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM","No prior breast radiation on side of planned NSM","Tumor \\\u003C0.5cm from NAC (including suspicious calcifications or MRI enhancement)","No planned post mastectomy radiation (PMRT)","No nicotine use within 4 weeks of surgical date",[104,105],"Planned autologous reconstruction (immediate or delayed)","Pregnancy","Inclusion Criteria:\n\n* Female patients age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Planned nipple sparing mastectomy (NSM)\n* Ideal NSM candidates would meet the following criteria:\n\n  * Cup size A-C\n  * BMI \\\u003C34\n  * Ptosis grade \\\u003C 2\n  * Clinical stage 0 - T2N0\n  * Final planned implant volume \\\u003C 400cc\n  * Inframammary or lateral mammary incision\n  * Tumor \\> 0.5cm from the nipple areolar complex (NAC)\n  * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM\n  * No prior breast radiation on side of planned NSM\n  * Tumor \\\u003C0.5cm from NAC (including suspicious calcifications or MRI enhancement)\n  * No planned post mastectomy radiation (PMRT)\n  * No nicotine use within 4 weeks of surgical date\n\nExclusion Criteria:\n\n* Planned autologous reconstruction (immediate or delayed)\n* Pregnancy",[108,109],"ADULT","OLDER_ADULT",[111],{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":128},"Mayo Clinic in Florida","Jacksonville","Florida","32224-9980","United States",[118,123,126],{"name":119,"role":120,"phone":121,"email":122},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":124,"role":125},"James W. Jakub, M.D.","PRINCIPAL_INVESTIGATOR",{"name":127,"role":125},"Olivia S. Ho, M.D., M.S.",{"lat":129,"lon":130},30.33218,-81.65565,[132],{"name":119,"role":120,"phone":121,"email":122},[134,135],{"name":124,"affiliation":13,"role":125},{"name":127,"affiliation":13,"role":125},[],[138],{"label":139,"url":140},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":142,"biomarkers":144},[143],"Breast Carcinoma",[],{"nct_id":4,"found":146,"summary":147,"prompt_version":157},true,{"design":148,"status":149,"heading":150,"summary":151,"follow_up":152,"word_count":153,"commitments":154,"compensation":155,"drugs_mentioned":156},"This is an interventional study that will randomly assign participants to either receive standard nipple-sparing mastectomy (NSM) or NSM with neurotization. It aims to enroll 20 women.","completed","Neurotization for Sensation After Nipple Sparing Mastectomy","This study is looking at whether patients who have a nipple-sparing mastectomy (NSM) are willing to join a larger study comparing NSM with or without a procedure called neurotization. Neurotization is a surgical technique that uses a nerve graft to try and restore sensation to the nipple and areola (the darker skin around the nipple). Many patients who have NSM report less nipple sensation, and this study also wants to see if neurotization can improve quality of life and sexual function. This study is for women aged 18 or older who are planning to have an NSM for certain stages of breast cancer (Anatomic Stage 0, I, or IIA). The main goal is to see how many patients are willing to participate in a randomized study comparing these two approaches. About 20 patients are expected to enroll.","Participants will be followed for up to 2 years after their surgery, with appointments at 14 days, and at 6, 12, and 24 months.",137,"Participants will undergo either a standard NSM or an NSM with a nerve graft. They will also complete questionnaires and have follow-up appointments.","Not stated in the trial record.",[],"v2"]