RecruitingNot Applicable

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

United States400 participantsStarted 2022-02-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Breast Q scores

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in Gender-Q scores

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in cold detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in warm detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in heat pain threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in mechanical detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in two-point discrimination

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Trial details

NCT IDNCT06094257

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2033-03

Contact for this trial

Lisa Gfrerer, MD, PhD

646.962.4250 lig4013@med.cornell.edu

View on ClinicalTrials.gov More Sensation Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Breast Q scores

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in Gender-Q scores

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in cold detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in warm detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in heat pain threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in mechanical detection threshold

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year

Change in two-point discrimination

Timeframe: preoperative, postoperative at 1 month, 3 months, 6 months, and 1 year