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.
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).
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).
Parallel
Autologous Breast Reconstruction With Direct Neurotization
Procedure/SurgeryThe 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
Autologous Breast Reconstruction without Neurotization
Procedure/SurgeryBreast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.
Breast Sensation assessed by using Semmes-Weinstein Monofilament testing
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
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.
Neuregulin 1 Expression
NRG1 expression quantified by ELISA from flap tissue
Nerve Cross-sectional Area
Nerve cross-sectional area measured via histomorphometry/histopathology using the recipient nerve of the direct neurotization method
Breast Morphometry
Breast morphometry assessed using a validated AR/3D application
Intraepidermal Nerve Fibre Density (IENFD)
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
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