Recruiting

Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in…

ClinicalTrials.gov IDNCT06094257

PhaseNot Applicable

Enrollment400

SponsorWeill Medical College of Cornell University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Sensation Disorders, Sensation, Phantom, Pain, Postoperative, Pain, Chronic, Numbness, Sensory Disorder, Sensory Defect, Phantom Pain, Phantom Sensation

About this study

Interventions

Diagnostic Test: Sensory testing — Quantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)

Primary outcomes

Change in Breast Q scores (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in Gender-Q scores (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in cold detection threshold (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in warm detection threshold (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in heat pain threshold (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in mechanical detection threshold (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in two-point discrimination (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)
Change in mechanical pain threshold (preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year)

Eligibility information

Inclusion Criteria: * Age over 18 * Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction * Patient is capable and willing to provide informed consent Exclusion Criteria: * Patient has a nerve condition that does not allow for assessment of sensation * Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule * Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy * Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)

Study locations

Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Weill Cornell Medicine, New York, New York 10065 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.