Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy
Extracellular Vesicles as Predictive Biomarkers for Chemotherapy-Induced Peripheral Neuropathy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
120 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 gastrointestinal cancer and is scheduled to receive oxaliplatin or capecitabine as part of standard care
- Has lung cancer and is scheduled to receive cisplatin, carboplatin, or docetaxel as part of standard care
- Has urologic cancer and is scheduled to receive carboplatin, cisplatin, paclitaxel, docetaxel, or enfortumab vedotin as part of standard care
- Has head and neck cancer and is scheduled to receive carboplatin, paclitaxel, or cisplatin as part of standard care
Exclusion Criteria2
- Has already been diagnosed with CIPN
- Has a neurodegenerative disease
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Interventions
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.
Collection of blood samples for isolation, quantification, and molecular characterization of circulating EVs, including analysis of membrane lipid composition and microRNA content.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07558447