Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ID
NCT07558447
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CIPN assessment — PROCEDURE
    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 — OTHER
    Collection of blood samples for isolation, quantification, and molecular characterization of circulating EVs, including analysis of membrane lipid composition and microRNA content.

Study Details

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.

Key Dates

First listed
Apr 30, 2026
Start date
Jan 1, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Baseline (T0)
    Patients eligible to receive antineoplastic compounds with taxanes, platinum compounds, or antimitotic agents, evaluated before the start of chemotherapy (baseline).
  • Other: End of Chemotherapy (T1)
    Patients who have completed the planned chemotherapy cycles with taxanes, platinum compounds, or antimitotic agents and are evaluated at the end of treatment.
  • Other: Follow-up (T2)
    Patients evaluated six months after completion of chemotherapy.

Primary Outcome Measure

Change from Baseline in Circulating EV Concentration [ Time Frame: 11 months from enrollment (T0), to completion of chemotherapy (T2) ]

Central Contacts

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