Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07558447

Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2026-04-30

120

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Has already been diagnosed with CIPN
  • Has a neurodegenerative disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

SC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

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Research Team

M

Massimiliano Ruscica, PhD

CONTACT

O

Ornella Garrone, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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