The goal of this clinical trial is to learn whether extracellular vesicles (EVs) in the blood can be used as biomarkers to predict chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients receiving chemotherapy with taxanes, platinum compounds, or antimitotic drugs. The main questions the study aims to answer are whether blood levels of EVs change in patients who develop CIPN during and after chemotherapy and whether specific features of EVs, including lipids and microRNAs, are associated with the development and severity of CIPN. Participants will be followed from before the start of chemotherapy until six months after treatment ends to evaluate how changes in EVs relate to nerve damage caused by chemotherapy. During the study, participants will provide blood samples before chemotherapy, at the end of treatment, and six months later for measurement and molecular analysis of EVs, will complete questionnaires about neuropathy symptoms, and will undergo simple, non-invasive nerve function tests using a tuning fork (diapason) and a Neuropen device. This study does not test cancer drugs; instead, it aims to identify biological markers in blood that may help predict which patients are at higher risk of developing CIPN, with the goal of improving monitoring and care during cancer treatment.
Has signed the informed consent form
Is 18 years of age or older
Is male or female
Has breast cancer and is scheduled to receive paclitaxel, docetaxel, eribulin, capecitabine, or carboplatin as part of standard care
Has already been diagnosed with CIPN
Has a neurodegenerative disease
Single group
CIPN assessment
Procedure/SurgeryAssessment of CIPN using a combination of physician-based and patient-reported measures. Objective evaluation includes assessment of vibration sensitivity. Patient-reported symptoms are assessed using the EORTC-CIPN20 questionnaire (Italian version), a 20-item self-administered questionnaire completed in approximately 10 minutes.
EV blood analysis
Other interventionCollection of blood samples for isolation, quantification, and molecular characterization of circulating EVs, including analysis of membrane lipid composition and microRNA content.
Change from Baseline in Circulating EV Concentration
Change in the concentration of circulating extracellular vesicles, expressed as vesicles per microliter of plasma, measured by comparing values at the end of chemotherapy (T1) and 6 months after completion of treatment (T2) with baseline at initiation of chemotherapy (T0), in relation to the development of chemotherapy-induced peripheral neuropathy. T1 corresponds to 5 months. T2 corresponds to 6 months after completion of treatment.
Change from End of Chemotherapy in Circulating EV Concentration
Change in the concentration of circulating extracellular vesicles, expressed as vesicles per microliter of plasma, measured by comparing values at the end of chemotherapy (T1) and 6 months after completion of treatment (T2) with baseline at initiation of chemotherapy (T0), in relation to the development of chemotherapy-induced peripheral neuropathy. T1 corresponds to 5 months. T2 corresponds to 6 months after completion of treatment.
Changes in EV Membrane Lipid Composition
The relative abundance of major EV membrane lipid classes-phosphatidylcholine, sphingomyelin, and cholesterol-will be quantified using targeted lipidomic analysis (e.g., mass spectrometry-based lipid profiling). Lipid levels will be expressed as mol (%) within EV samples collected at T0 (baseline), at the end of chemotherapy (T1 corresponding to 5 months) and at T2 (corresponding to 6 months after completion of treatment). Changes in lipid composition over time will be summarized descriptively and compared among time points (T1 vs T1 and T0 vs T2) to assess chemotherapy-associated alterations in EV membrane lipid profiles.
Changes in Extracellular Vesicle microRNA Profile
Changes in the microRNA content of circulating extracellular vesicles measured at T0 (baseline), at the end of chemotherapy (T1 corresponding to 5 months from the initiation of chemotherapy) and at the end of chemotherapy (T2).
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