Actively Recruiting
Prospective Cohort Study Comparing Sensory Outcome, Chronic Pain, Phantom Pain, and Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation
Led by Weill Medical College of Cornell University · Updated on 2025-08-27
400
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of sensory nerve preservation and reconnection during mastectomy surgeries, including gender-affirming mastectomy, implant-based breast reconstruction, and autologous breast reconstruction. The study aims to compare postoperative sensation and patient satisfaction between patients who receive surgical nerve reinnervation and those who do not. This research addresses the common issues of reduced sensation, chronic pain, and phantom pain occurring after mastectomy by using advanced nerve surgery techniques and comprehensive sensory testing. The study groups include patients undergoing nipple sparing mastectomy with implant reconstruction, nipple sparing mastectomy with autologous reconstruction, gender mastectomy with free nipple grafting, and a control group matched by surgical procedure, age, BMI, and mastectomy weight. Sensory outcomes will be measured with quantitative sensory testing (QST) that assesses multiple sensory functions such as cold, warm, pain, pressure, vibration, and two-point discrimination. Patient-reported outcomes will also be collected to evaluate satisfaction and pain levels over time. Participants will undergo assessments before surgery and at 1 month, 3 months, 6 months, and 1 year postoperatively, with some measures continuing annually up to 10 years. The study involves physical examinations, QST, and questionnaires to track changes in sensation, pain thresholds, and patient satisfaction. The research team will analyze sensory recovery, the incidence of chronic and phantom pain, and overall patient experience to inform future guidelines and potential broader clinical trials.
CONDITIONS
Brief Title
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft)
- Scheduled for nipple sparing mastectomy with breast implant or autologous reconstruction
- Capable and willing to provide informed consent
You will not qualify if you...
- Presence of a nerve condition preventing assessment of sensation
- Considered unsuitable for study inclusion or unlikely to comply with follow-up by the investigator
- Currently prescribed medication known to impact nerve regeneration or cause peripheral neuropathy
- Undergoing bilateral reconstruction with non-uniform treatment (one breast neurotized, the other non-neurotized)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo gender mastectomy, nipple sparing mastectomy with implant reconstruction, or nipple sparing mastectomy with autologous reconstruction, with or without nerve reinnervation.
1 visit (in-person)
Duration - Preoperative and postoperative assessments at 1 month, 3 months, 6 months, and 1 year
Participants undergo quantitative sensory testing (QST) and patient-reported outcome measures (PROMs) before surgery and at multiple time points after surgery to assess sensation, pain, and satisfaction.
5 visits (in-person) including 1 preoperative and 4 postoperative visits
Duration - Annually for 2 to 10 years post-operation
Participants are monitored annually for up to 10 years after surgery to assess long-term sensory outcomes, chronic pain, phantom pain, and satisfaction.
Annual visits for up to 9 visits (in-person)
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
L
Lisa Gfrerer, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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