Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

Condition(s) studied

Investigational drug(s) / intervention(s)

CIPN assessment: Assessment 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: Collection of blood samples for isolation, quantification, and molecular characterization of circulating EVs, including analysis of membrane lipid composition and microRNA content.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Circulating EV Concentration — 11 months from enrollment (T0), to completion of chemotherapy (T2)
  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.

Trial sites (1)

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