RecruitingNCT06094257

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.


Sponsor

Weill Medical College of Cornell University

Enrollment

400 participants

Start Date

Feb 9, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how sensation (the ability to feel touch) changes and recovers over time in people who have had mastectomy surgery — either for breast cancer or gender-affirming reasons. The goal is to better understand nerve regeneration after surgery, which could lead to improved surgical techniques. **You may be eligible if...** - You are over 18 years old - You are scheduled for a gender-affirming mastectomy or a nipple-sparing mastectomy (with reconstruction using implants or your own tissue) - You are willing and able to give informed consent **You may NOT be eligible if...** - You have a nerve condition that prevents accurate sensation testing - You are taking medications known to affect nerve growth or cause nerve damage - You are having two different types of reconstruction on each side (one with and one without nerve repair) - Your surgeon determines you are not a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTSensory 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)


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Weill Cornell Medicine

New York, New York, United States

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NCT06094257


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