RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2022-02-09
Study Completion:2033-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06094257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age over 18
  2. * 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
  3. * Patient is capable and willing to provide informed consent
  1. * Patient has a nerve condition that does not allow for assessment of sensation
  2. * 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
  3. * Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
  4. * Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)

Contacts and Locations

Study Contact

Lisa Gfrerer, MD, PhD
CONTACT
646.962.4250
lig4013@med.cornell.edu

Principal Investigator

Lisa Gfrerer, MD, PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Lisa Gfrerer, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-09
Study Completion Date2033-03

Study Record Updates

Study Start Date2022-02-09
Study Completion Date2033-03

Terms related to this study

Keywords Provided by Researchers

  • Sensation
  • Reinnervation
  • Peripheral nerve
  • Reconstruction
  • Breast reinnervation
  • Chest reinnervation
  • Gender-affirming mastectomy
  • Breast reconstruction
  • Peripheral nerve repair
  • Targeted nipple areolar complex
  • Targeted nipple areolar complex reinnervation

Additional Relevant MeSH Terms

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