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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06094257
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sensory testing — DIAGNOSTIC_TEST
    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)

Study Details

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 patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.

Key Dates

Start date
Feb 9, 2022
Status verified
Aug 2025
Primary completion
Mar 31, 2033
Completion
Mar 31, 2033

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Nipple sparing mastectomy (NSM) and implant reconstruction
    Nipple sparing mastectomy (NSM) and implant reconstruction
  • Arm: Nipple sparing mastectomy (NSM) and autologous reconstruction
    Nipple sparing mastectomy (NSM) and autologous reconstruction
  • Arm: Gender mastectomy with free nipple grafting
    Gender mastectomy with free nipple grafting
  • Arm: Control patients matched by surgical procedure, age, BMI and mastectomy weight.
    Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Primary Outcome Measure

Change in Breast Q scores [ Time Frame: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Lisa Gfrerer, MD. PhD
[email protected]
(646) 962-2330
Lisa Gfrerer, MD, PhD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Lisa Gfrerer, MD, PhD
[email protected]
646.962.4250
Lisa Gfrerer, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MAWeill Cornell Medicine· New York, NY

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