Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

NCT07558447 | Recruiting

• 1 other identifier: 5648
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer; Lung Cancer; Urologic Cancer; Head and Neck Cancer; Breast Cancer; Chemotherapy-Induced Peripheral Neuropathy

Keywords

Chemotherapy-Induced Peripheral Neuropathy; Neurotoxicity; Extracellular Vesicles; Biomarkers; Liquid Biopsy; Paclitaxel; Docetaxel; Eribulin; Capecitabine; Carboplatin; Oxaliplatin; Cisplatin; Enfortumab Vedotin; Neuropathy; Cancer

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Circulating EV Concentration

  Change in the concentration of circulating extracellular vesicles, expressed as vesicles per microliter of plasma, measured by comparing values at the end of chemotherapy (T1) and 6 months after completion of treatment (T2) with baseline at initiation of chemotherapy (T0), in relation to the development of chemotherapy-induced peripheral neuropathy. T1 corresponds to 5 months. T2 corresponds to 6 months after completion of treatment.

  11 months from enrollment (T0), to completion of chemotherapy (T2)

Secondary Outcomes (3)

• Change from End of Chemotherapy in Circulating EV Concentration

  11 months from enrollment (T0), to completion of chemotherapy (T2)

• Changes in EV Membrane Lipid Composition

  11 months from enrollment (T0), to completion of chemotherapy (T2)

• Changes in Extracellular Vesicle microRNA Profile

  11 months from enrollment (T0), to completion of chemotherapy (T2)

Study Arms (3)

Baseline (T0)

OTHER

Patients eligible to receive antineoplastic compounds with taxanes, platinum compounds, or antimitotic agents, evaluated before the start of chemotherapy (baseline).

Procedure: CIPN assessment; Other: EV blood analysis

End of Chemotherapy (T1)

OTHER

Patients who have completed the planned chemotherapy cycles with taxanes, platinum compounds, or antimitotic agents and are evaluated at the end of treatment.

Procedure: CIPN assessment; Other: EV blood analysis

Follow-up (T2)

OTHER

Patients evaluated six months after completion of chemotherapy.

Procedure: CIPN assessment; Other: EV blood analysis

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.

Baseline (T0); End of Chemotherapy (T1); Follow-up (T2)

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.

Baseline (T0); End of Chemotherapy (T1); Follow-up (T2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

SC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Lung Neoplasms; Urologic Neoplasms; Head and Neck Neoplasms; Neurotoxicity Syndromes; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Ornella Garrone, MD

  Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

  STUDY CHAIR

• Massimiliano Ruscica, PhD

  Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Ruscica, PhD

CONTACT

0039 0250318220; massimiliano.ruscica@unimi.it

Ornella Garrone, MD

CONTACT

0039 0255032556; ornella.garrone@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-group, longitudinal interventional study in which all participants undergo the same study procedures. Patients receiving chemotherapy are followed over time, with repeated blood sampling and neurological assessments performed at predefined time points before treatment, at the end of therapy, and six months after completion. Each participant serves as their own reference, allowing evaluation of within-subject changes in extracellular vesicle measurements and their relationship to the development of chemotherapy-induced peripheral neuropathy.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-01

Locations

IT (1)