Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.
1 other identifier
observational
400
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2022
CompletedFirst Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
August 27, 2025
August 1, 2025
11.1 years
October 3, 2023
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Change in Breast Q scores
All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in Gender-Q scores
All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in cold detection threshold
Thermal detection measured by Medoc TSA system
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in warm detection threshold
Thermal detection measured by Medoc TSA system
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in heat pain threshold
Thermal detection measured by Medoc TSA system
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in mechanical detection threshold
Measured by MRC Opti Hair von Frey Filaments
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in two-point discrimination
Measured by MRC Opti Hair von Frey Filaments
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in mechanical pain threshold
Measured by MRC Pinprick Stimulator
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in pressure pain threshold
Measured by Medoc Pressure algometer
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in Tinel sensation
Measure on physical exam
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Change in vibration sensation
Measured by tuning fork
preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year
Secondary Outcomes (11)
Change in Breast Q scores long term
Annually at 2-10 years post-operation
Change in Gender Q scores long term
Annually at 2-10 years post-operation
Change in vibration sensation
Annually at 2-10 years post-operation
Change in Tinel sensation
Annually at 2-10 years post-operation
Change in pressure pain threshold
Annually at 2-10 years post-operation
- +6 more secondary outcomes
Study Arms (4)
Nipple sparing mastectomy (NSM) and implant reconstruction
Nipple sparing mastectomy (NSM) and implant reconstruction
Nipple sparing mastectomy (NSM) and autologous reconstruction
Nipple sparing mastectomy (NSM) and autologous reconstruction
Gender mastectomy with free nipple grafting
Gender mastectomy with free nipple grafting
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Interventions
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)
Eligibility Criteria
Massachusetts General Hospital (MGH) and Weill Cornell Medicine (WCM) are ideally suited for enrollment of patients in this study. Both institutions are high-volume center of expertise for gender affirming mastectomy and breast reconstructions as well as peripheral nerve surgery. Patients will be matched by BMI, age and mastectomy weight. Patients scheduled to undergo gender affirming mastectomy or breast reduction surgery at MGH and WCM will be evaluated for the study and will be presented with the option to hear about the study by our research assistant. Those interested in the study will be presented with all the necessary details required by the IRB including a study fact sheet. Verbal consent will be obtained and documented.
You may qualify if:
- 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
You may not qualify if:
- Patient has a nerve condition that does not allow for assessment of sensation
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Weill Cornell Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Gfrerer, MD, PhD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2023
First Posted
October 23, 2023
Study Start
February 9, 2022
Primary Completion (Estimated)
March 1, 2033
Study Completion (Estimated)
March 1, 2033
Last Updated
August 27, 2025
Record last verified: 2025-08