NCT07558447 Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy
| NCT ID | NCT07558447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Has already been diagnosed with CIPN * Has a neurodegenerative disease
Contact & Investigator
Ornella Garrone, MD
STUDY CHAIR
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Frequently Asked Questions
Who can join the NCT07558447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07558447 currently recruiting?
Yes, NCT07558447 is actively recruiting participants. Contact the research team at massimiliano.ruscica@unimi.it for enrollment information.
Where is the NCT07558447 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07558447 clinical trial?
NCT07558447 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The principal investigator is Ornella Garrone, MD at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano. The trial plans to enroll 120 participants.