Breast ReconstructionNCT06629012
Autologous Nerve Graft Breast Reconstruction Neurotization
An observational study of Breast Reconstruction and Breast Cancer Patients, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Breast Cancer Patients, Nipple-sparing Mastectomy
- What is being tested?
- Breast reconstruction with neurotization and Breast reconstruction without neurotization
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Nov 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction
Who may be able to join
- Patient who receive breast reconstruction
- Patient who is willing to fill in the questionnaire
Who cannot join
- Patient who receive breast reconstruction for the reason other than breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Neurotization During Breast Reconstruction Enhances Quality of Life
The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.
- Being tested
- Breast reconstruction with neurotization, Breast reconstruction without neurotization
- Keywords
- breast reconstruction, nipple-sparing mastectomy, breast neurotization, quality of life, autologous nerve graft, nipple sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstruction with neurotizationProcedure or surgery
Patients received breast reconstruction with neurotization procedure
Breast reconstruction without neurotizationProcedure or surgery
Patients received breast reconstruction without neurotization
| Study group | Role | What they receive |
|---|---|---|
| Innervated group | Patients received breast neurotization Receives: Procedure: Breast reconstruction with neurotization | |
| Non-innervated group | Patients did not receive breast neurotization Receives: Procedure: Breast reconstruction without neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Quality of life
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Measured: Before breast reconstructive surgery
Post-operative-two-year Quality of life
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Measured: Two-year after breast reconstructive surgery
Post-operative-one-year Quality of life
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Measured: One-year after breast reconstructive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start29 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Ju Huang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629012
- Sponsor's protocol ID
- 202101923B0-N
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Neurotization During Breast Reconstruction Enhances Quality of Life
- ClinicalTrials.gov ID
- NCT06629012
- Acronym / sponsor ID
- 202101923B0-N
- Keywords
- breast reconstruction, nipple-sparing mastectomy, breast neurotization, quality of life, autologous nerve graft, nipple sensation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innervated group | – | Procedure: Breast reconstruction with neurotizationPatients received breast neurotization |
| Non-innervated group | – | Procedure: Breast reconstruction without neurotizationPatients did not receive breast neurotization |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing nipple-sparing mastectomy and immediate breast reconstruction
Key inclusion criteria (2 listed)
- Patient who receive breast reconstruction
- Patient who is willing to fill in the questionnaire
Key exclusion criteria (1 listed)
- Patient who receive breast reconstruction for the reason other than breast cancer
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 |
|---|---|---|
| Breast reconstruction with neurotizationPatients received breast reconstruction with neurotization procedure | Procedure or surgery | Innervated group |
| Breast reconstruction without neurotizationPatients received breast reconstruction without neurotization | Procedure or surgery | Non-innervated group |
Primary outcome
Pre-operative Quality of life
Time frame: Before breast reconstructive surgery
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Post-operative-two-year Quality of life
Time frame: Two-year after breast reconstructive surgery
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Post-operative-one-year Quality of life
Time frame: One-year after breast reconstructive surgery
Patient-reported outcome assessed by the BREAST-Q™ Reconstruction module questionnaire and a additional questionnaire regarding sensation, nipple satisfaction, and breast symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Patient privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Breast Cancer Patients, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Pre-operative Quality of life (time frame: Before breast reconstructive surgery). The study lists 3 primary outcomes in all. 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 22 Oct 2026.