Trial Title:
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
NCT ID:
NCT06094257
Condition:
Sensation Disorders
Sensation, Phantom
Pain, Postoperative
Pain, Chronic
Numbness
Sensory Disorder
Sensory Defect
Phantom Pain
Phantom Sensation
Conditions: Official terms:
Phantom Limb
Sensation Disorders
Pain, Postoperative
Chronic Pain
Conditions: Keywords:
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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Sensory testing
Description:
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)
Arm group label:
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Arm group label:
Gender mastectomy with free nipple grafting
Arm group label:
Nipple sparing mastectomy (NSM) and autologous reconstruction
Arm group label:
Nipple sparing mastectomy (NSM) and implant reconstruction
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.
Detailed description:
SIGNIFICANCE
During removal of breast tissue that is required for mastectomy procedures, the nerves
that supply the breast skin and the nipple areola complex (NAC) are sacrificed. This
results in fair to poor sensation in 50-90% of patients, decreased patient satisfaction
and increased risk of injury. Further, when nerves are transected, axons sprout from the
proximal free nerve end and form neuromas that cause chronic pain (CP) and phantom pain
(PP) in ~60% and 30-80% of patients, respectively. With the implementation of advanced
peripheral nerve surgery techniques, it has become possible to preserve, transfer and
graft nerves to the insensate areas of the reconstructed breast/chest to provide
sensation in cancer and transgender patients. Multiple studies have shown increased
patient satisfaction and sensation after reinnervation as compared to no reinnervation.
However, there are several limitations to currently published clinical outcome studies:
1)Lack of comprehensive objective outcome measures to test all aspects of the
somatosensory nervous system. No study to date has utilized the protocol for Quantitative
Sensory Testing (QST) that was developed by the German Research Network on Neuropathic
Pain (DFNS) and provides a validated and standardized approach to test all nociceptive
and non- nociceptive sensory functions including small unmyelinated C fibers, myelinated
A-alpha, A-beta, and A-delta fibers. This comprehensive, standardized and validated
approach has been adopted internationally to evaluate sensory conditions and allows for
objective outcome assessment and comparison. 2)Gap in knowledge regarding reinnervation
outcomes after implant- based reconstruction. Most sensory studies were performed in
patients undergoing autologous reconstruction with only few studies discussing
reinnervation in the context of implant- based breast reconstruction. However, the most
common type of reconstruction after breast cancer remains implant based reconstruction
accounting for 80% of breast reconstruction cases. Therefore, it is important to
investigate this population further to determine whether reinnervation is successful and
should be offered to this patient population. 3)Limited understanding of sensory outcome
after transgender mastectomy. Sensory outcome is important to >90% of patients undergoing
transgender mastectomy with free nipple grafting (FNG), which is the most common
procedure performed in transgender patients. Our team has described chest reinnervation
in this patient population with good sensory outcomes. However, a prospective clinical
trial with comprehensive outcome measurements including QST and patient reported outcome
measures (PROMs) with control group is required to further examine the role of
reinnervation in transgender chest surgery. 4)Insufficient prospective data on PP and CP.
There are very few prospective studies reporting the incidence of PP and CP after cancer
and transgender mastectomy and the results are inconsistent. Further, the percentage of
chronic breast/chest pain patients with true neuropathic pain (NP) is unclear. In
addition, although we know from other patient populations (amputees) that nerve
reconstruction significantly decreases the incidence of CP and PP, there is no data on
whether breast reinnervation influences the percentage of patients who will develop these
conditions. 5)Prospective comparison of reinnervation outcomes between autologous
reconstruction, implant reconstruction and gender mastectomy has not been performed.
Breast reinnervation has rapidly evolved and is becoming a widely employed addition to
breast and chest reconstruction. However, it remains unclear how these patient
populations compare, and which patients obtain good sensory outcome warranting the longer
operative times and higher cost of reinnervation.
The broad objective of this proposal is to prospectively compare objective data on
sensory outcomes using QST and PROMs in patients undergoing reinnervation after A) nipple
sparing mastectomy (NSM) and implant reconstruction B) NSM and autologous reconstruction
C) gender mastectomy with FNG and D) control patients matched by surgical procedure, age,
BMI and mastectomy weight. This preliminary data will be used to apply for government
funding (NIH K23) to conduct a randomized controlled multi- center clinical trial to
evaluate reinnervation versus no reinnervation after mastectomy in cancer and transgender
care. The objectives of this larger scale study are to A) obtain objective QST sensory
measurements and PROM outcomes across institutions, B) determine the chances of
reinnervation success based on variables such as patient factors (age, comorbidities,
adjuvant treatment), mastectomy factors (incision type, mastectomy weight), breast
reconstruction techniques (retropectoral, prepectoral, direct- to implant, expander
reconstruction, implant size, implant type, types of autologous reconstruction), chest
reconstruction techniques and nerve transfer techniques (number of nerves, length of
allograft, size of allograft etc.) C) perform a cost- benefit analysis and D) develop
evidence-based guidelines for breast/ chest reinnervation after mastectomy.
SPECIFIC AIMS
All aims will analyze and compare the following patient groups: a) NSM and implant
reconstruction with reinnervation b) NSM with autologous reconstruction with
reinnervation c) gender mastectomy with FNG with reinnervation d) controls matched by
surgical procedure (implant, autologous, transgender), BMI, age, gender and mastectomy
weight.
Aim 1A: Analysis of all aspects of sensation with QST. Aim 1B: Evaluation of timing of
return of sensation. Aim 2: Assessment of CP and PP. Aim 3: Analysis of patient
satisfaction.
HYPOTHESIS
Breast reinnervation does not improve sensation/patient satisfaction as compared to
mastectomy with no reinnervation. Further, there is no difference in prevalence of CP and
PP.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Gfrerer, MD. PhD
Phone:
646-962-2330
Email:
lgfrerer@partners.org
Investigator:
Last name:
Lisa Gfrerer, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Gfrerer, MD, PhD
Phone:
646-962-4250
Email:
lig4013@med.cornell.edu
Investigator:
Last name:
Lisa Gfrerer, MD, PhD
Email:
Principal Investigator
Start date:
February 9, 2022
Completion date:
March 2033
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06094257
