NCT07558447Recruiting
Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy
Extracellular Vesicles as Predictive Biomarkers for Chemotherapy-Induced Peripheral Neuropathy
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Head and neck cancer, Lung cancer
- NCT number
- NCT07558447
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Jan 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has a neurodegenerative disease
Other
- Has already been diagnosed with CIPN
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.