Breast ReconstructionNCT05206565
Effect of Neurotization on QoL and Sensory Restoration
A study testing Neurotization - Autologous Reconstruction with DIEP/TRAM in people with Breast Reconstruction and Neurotization, run by University of Wisconsin, Madison.
Trial summary
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Neurotization
- What is being tested?
- Neurotization - Autologous Reconstruction with DIEP/TRAM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide informed consent
- The patient is ≥ 18 years
- Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included
Who cannot join
- Patient is non-English speaking
- Patient is known or believed to be pregnant
- Patient is a minor (individuals <18 years old)
- Patient is a prisoner
- Individuals unable to give consent due to another condition such as impaired decision-making capacity
- Autologous reconstruction where the flap is buried (e.g. there is no autologous skin exposed for sensation testing)
Show all 15Show fewer
- Patient is a male
- Any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy
- Women with recurrent breast cancer
- Women who have undergone previous breast reconstructive procedures
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patient is currently lactating
- History of radiation therapy
- Patient undergoing a latissimus dorsi flap for reconstruction
- Patient undergoing alloplastic reconstruction
About this study
Official title: The Effect of Neurotization on Quality of Life and Sensory Restoration After Autologous Breast Reconstruction
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.
Read the detailed description
In 2019, nearly one third of cancers diagnosed in the United States were breast cancers. Per the Plastic Surgery procedural statistics from the American Society of Plastic Surgery database, that same year approximately 107,000 patients decided to pursue either alloplastic (ex. Tissue expander or implant based) or autologous (ex. Transverse Rectus Abdominis Muscle (TRAM), Deep Inferior Epigastric Perforator (DIEP) flaps) breast reconstruction, an increase of 5% from 2018. Over the past few decades, as surgical techniques have continued to improve, postoperative concerns have transitioned towards the patient's aesthetic outcome and satisfaction. While the appropriate size, shape, and symmetry of the breast are crucial goals to achieve, another issue facing patients is that without sensation the reconstructed breast does not feel like their own. In most patients there is diminished, if not absent, sensation in the reconstructed breast. The lack of sensation can not only put patients at risk of injury, but also can impact their lives sexually and socially.
The goal of this randomized, double-blinded study is to prospectively evaluate the impact of neurotization on breast-specific quality of life in patients who have undergone autologous reconstruction. Secondary objectives are to also look at additional health-related quality of life outcomes using validated surveys (e.g. PROMIS and NIH Toolbox). These NIH-funded surveys will be analyzed to assess factors important to surgical impact on physical function, mental function, social function, pain, and sexual function. Finally, investigators will objectively measure differences in sensation. Investigators hypothesize that breast neurotization will improve both breast- and health-related patient quality of life outcomes as well as objective sensation. The duration of this study is expected to be approximately 48 months in order to recruit an appropriate number of patients and have adequate postoperative follow up.
- Conditions
- Breast Reconstruction, Neurotization
- Being tested
- Neurotization - Autologous Reconstruction with DIEP/TRAM
- Keywords
- Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotization - Autologous Reconstruction with DIEP/TRAMProcedure or surgery
- Transverse Rectus Abdominis Muscle/Deep Inferior Epigastric Artery Flap Harvest - Prior to elevation of flaps in the suprafascial plane from using loupe magnification to identify medial and lateral row of perforators bilaterally, sensory nerves T10-12 are identified and dissected into the muscle bilaterally to prepare for nerve coaptation, nerves are divided at the level of the fascia where they are pure sensory nerves.
- Chest Intercostal Nerve Harvest - During standard of care chest vessel dissection, intercostal nerves T3-4 are identified. After completion of vein coupling it will be determined whether neurotization can be performed or if autograft. Primary nerve coaptation will be performed if there is adequate length for direct end to end apposition.
- Coaptation of nerve or nerve graft endings will be performed using 9-0 nylon suture in an interrupted fashion.
| Study group | Role | What they receive |
|---|---|---|
| Autologous with TRAM/DIEP flaps, with neurotization | Experimental | Autologous with TRAM/DIEP flaps, with neurotization Receives: Procedure: Neurotization - Autologous Reconstruction with DIEP/TRAM |
| Autologous with TRAM/DIEP flaps, without neurotization | No intervention | Autologous with TRAM/DIEP flaps, without neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization.
This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
Measured: approximately 12 months after reconstruction
Secondary outcomes (8)
Change in Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization.
This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
The Patient-Reported Outcome Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities SF8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded so that higher scores represent fewer limitations (better abilities). The item bank does not use a time frame (e.g. over the past seven days) when assessing ability to participate in social roles and activities.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Pain Interference assessed by PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference SF8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". A lower score indicates the least amount of pain interference.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in PROMIS Psychosocial Illness Impact-Positive SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Measures the direct positive psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting better outcomes.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in PROMIS Psychosocial Illness Impact-Negative SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Measures the direct negative psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Pressure-Specified Sensory Device (PSSD) score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
The PSSD Sensory Score is based on 1-point static and 2-point static pressure thresholds and 2- point distances. Cutaneous pressure thresholds and inter-prong distances are reported by the PSSD and determined to be normal or abnormal at a 99% confidence limit based on age (</= 45, or >45). These results correlate to a grading scheme which combines 1- and 2-point static pressure threshold with 2-point distance. An increase of greater than or equal to 1 grade from baseline as measured with the PSSD will be considered a meaningful change. The grading scale integrates normative data for each PSSD testing site.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in mean monofilament value in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Each monofilament value represents the logarithm of the force in milligrams required to bend the monofilament. Therefore, a thinner monofilament requires less pressure to bend and, if felt by the participant, represents improved one-point static discrimination compared to a participant who is not able to feel it.
Perpendicular pressure will be applied to the same spot until monofilament bending is noted each time for a duration of 1.5 s, three times in succession, with intervals of 1.5 s. Testing will start with the thinnest monofilament and progress to monofilaments of increasing pressure until touch is identified in at least one out of three times by the participant. Participants will be asked to lay on their back and close their eyes, and measurements will take place in a quiet room. The different sites will be tested in a random sequence to ensure touch at a particular site cannot be predicted.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in number of touch sensitive breast locations in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
The participant will be tested at 9 different spots on the breast and the number of locations on the breast participant are able to detect the filament will be recorded.
Measured: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study startMar 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Departmental hold on accrual, study never reopened and never accrued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett F Michelotti, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206565
- Sponsor's protocol ID
- 2021-0290
- Other IDs
- A539730, UW21028, Protocol Version 9/29/2021
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurotization on Quality of Life and Sensory Restoration After Autologous Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05206565
- Acronym / sponsor ID
- 2021-0290
- Conditions
- Breast Reconstruction, Neurotization
- Keywords
- Quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Departmental hold on accrual, study never reopened and never accrued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-site, randomized, double-blinded trial to assess whether neurotization following autologous breast reconstruction in patients with breast cancer increases quality of life and sensation in the breast compared to breast reconstruction without neurotization. 50 participants will be enrolled and can expect to be on study for up to 18 months after reconstruction surgery.
Detailed description
In 2019, nearly one third of cancers diagnosed in the United States were breast cancers. Per the Plastic Surgery procedural statistics from the American Society of Plastic Surgery database, that same year approximately 107,000 patients decided to pursue either alloplastic (ex. Tissue expander or implant based) or autologous (ex. Transverse Rectus Abdominis Muscle (TRAM), Deep Inferior Epigastric Perforator (DIEP) flaps) breast reconstruction, an increase of 5% from 2018. Over the past few decades, as surgical techniques have continued to improve, postoperative concerns have transitioned towards the patient's aesthetic outcome and satisfaction. While the appropriate size, shape, and symmetry of the breast are crucial goals to achieve, another issue facing patients is that without sensation the reconstructed breast does not feel like their own. In most patients there is diminished, if not absent, sensation in the reconstructed breast. The lack of sensation can not only put patients at risk of injury, but also can impact their lives sexually and socially.
The goal of this randomized, double-blinded study is to prospectively evaluate the impact of neurotization on breast-specific quality of life in patients who have undergone autologous reconstruction. Secondary objectives are to also look at additional health-related quality of life outcomes using validated surveys (e.g. PROMIS and NIH Toolbox). These NIH-funded surveys will be analyzed to assess factors important to surgical impact on physical function, mental function, social function, pain, and sexual function. Finally, investigators will objectively measure differences in sensation. Investigators hypothesize that breast neurotization will improve both breast- and health-related patient quality of life outcomes as well as objective sensation. The duration of this study is expected to be approximately 48 months in order to recruit an appropriate number of patients and have adequate postoperative follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous with TRAM/DIEP flaps, with neurotization | Experimental | Procedure: Neurotization - Autologous Reconstruction with DIEP/TRAMAutologous with TRAM/DIEP flaps, with neurotization |
| Autologous with TRAM/DIEP flaps, without neurotization | No intervention | –Autologous with TRAM/DIEP flaps, without neurotization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to provide informed consent
- The patient is ≥ 18 years
- Patients presenting to UW Health who have had or will have unilateral or bilateral mastectomy (therapeutic or prophylactic) and are planning to undergo autologous reconstruction with TRAM/DIEP will be included
Key exclusion criteria (15 listed)
- Patient is non-English speaking
- Patient is known or believed to be pregnant
- Patient is a minor (individuals <18 years old)
- Patient is a prisoner
- Individuals unable to give consent due to another condition such as impaired decision-making capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotization - Autologous Reconstruction with DIEP/TRAM* Transverse Rectus Abdominis Muscle/Deep Inferior Epigastric Artery Flap Harvest - Prior to elevation of flaps in the suprafascial plane from using loupe magnification to identify medial and lateral row of perforators bilaterally, sensory nerves T10-12 are identified and dissected into the muscle bilaterally to prepare for nerve coaptation, nerves are divided at the level of the fascia where they are pure sensory nerves. * Chest Intercostal Nerve Harvest - During standard of care chest vessel dissection, intercostal nerves T3-4 are identified. After completion of vein coupling it will be determined whether neurotization can be performed or if autograft. Primary nerve coaptation will be performed if there is adequate length for direct end to end apposition. * Coaptation of nerve or nerve graft endings will be performed using 9-0 nylon suture in an interrupted fashion. | Procedure or surgery | Autologous with TRAM/DIEP flaps, with neurotization |
Primary outcome
Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: approximately 12 months after reconstruction
Self-reported, breast-specific health-related QoL(Quality of life) via use of the Breast-Q® in participant with breast cancer who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization. This score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 to 4 (Likert Scale). The sum of each domain raw score scale will be plotted in the Breast Q Conversion Table to convert the summed domain score to a Equivalent Rasch Transformed Score with values ranging from 0 (worst) to 100 (best).
8 secondary outcomes
Change in Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Pain Interference assessed by PROMIS SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in PROMIS Psychosocial Illness Impact-Positive SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in PROMIS Psychosocial Illness Impact-Negative SF8a score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in Pressure-Specified Sensory Device (PSSD) score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in mean monofilament value in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Change in number of touch sensitive breast locations in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization
Time frame: Baseline(pre-operative), approximately 1-3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 18 months after the reconstruction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett F Michelotti, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Neurotization - Autologous Reconstruction with DIEP/TRAM in people with Breast Reconstruction and Neurotization, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast-Q® score in participants who have undergone autologous reconstruction with TRAM/DIEP flaps with and without neurotization (time frame: approximately 12 months after reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.