Breast Reconstruction After Mastectomy, Mastectomy and Breast Reconstruction, Neurotization, Peripheral Nerve Regeneration, Quality of Life (QOL), Sensory Function
Conditions
Keywords
breast neurotization, mastectomy, breast sensory, quality of life
Brief summary
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. The study's primary questions are: 1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations? 2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module? As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include: 1. Neuregulin-1 (NRG1) expression in flap tissue biopsy; 2. Cross-sectional area of the recipient nerve fibres; 3. Breast morphometry measured at baseline and follow-up; 4. Intraepidermal nerve fibre density (IENFD) on skin biopsy. Participants will be randomly assigned to receive either: 1. Neurotized autologous breast reconstruction using fully autologous graft components, or 2. Standard (non-neurotized) autologous breast reconstruction. The study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery. Participants will undergo: 1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery. 2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months. 3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit. 3\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool. This study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.
Interventions
PROCEDUREAutologous Breast Reconstruction With Direct Neurotization
The direct neurotization using fully autologous components procedures include: 1. Direct neurotization is carried out using fully autologous components, involving coaptation of the recipient nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. 2. Surgical breast reconstruction is then completed using patient's own tissue
Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged ≥18 years. * Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy. * Patients undergoing breast reconstruction. * Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and/or chemotherapy or receiving no adjuvant therapy). * Willing to comply with all scheduled examinations and tissue sampling procedures. * Able and willing to provide written informed consent.
Exclusion criteria
* History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications). * Bilateral mastectomy. * Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment. * Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization). * Refusal or inability to attend follow-up evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Sensation assessed by using Semmes-Weinstein Monofilament testing | 1, 3 and 6 months after Neurotization | SWM thresholds at nine standardized points on the reconstructed breast will be measured using calibrated monofilaments, categorized into levels of normal touch, diminished light touch, diminished protective sensation, loss of protective sensation, and deep pressure only. |
| Patient's Quality of Life assessed by using BREAST-Q® Sensation Module | 1, 3 and 6 months after Neurotization | The patient reported outcomes will be recorded in BREAST-Q® Sensation Module to capture the sensation, breast symptoms, and quality of life impact of sensation loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuregulin 1 Expression | During procedure and 6 months after surgery | NRG1 expression quantified by ELISA from flap tissue |
| Nerve Cross-sectional Area | Measured during neurotization procedure | Nerve cross-sectional area measured via histomorphometry/histopathology using the recipient nerve of the direct neurotization method |
| Breast Morphometry | Before surgery and 1, 3, 6 months after surgery | Breast morphometry assessed using a validated AR/3D application |
| Intraepidermal Nerve Fibre Density (IENFD) | During procedure and 6 months after surgery | IENFD quantified by counting PGP9.5-positive intraepidermal fibers per mm of epidermal length. Flap skin tissue samples will be taken using 3 mm punch biopsy |
Countries
Indonesia
Contacts
Primary ContactMohamad Rachadian Ramadan, MD., MRBS.
Outcome results
None listed