System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT07558447 on ClinicalTrials.gov

Extracellular Vesicles and Chemotherapy-Induced Peripheral Neuropathy

Official title: Extracellular Vesicles as Predictive Biomarkers for Chemotherapy-Induced Peripheral Neuropathy

  • Sponsor: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Enrollment: 120 (Estimated)
  • Study start: 2025-01-01 (Actual)
  • Primary completion: 2026-09-01 (Estimated)
  • Study completion: 2026-09-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Single Group
  • InterventionModelDescription: 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.
  • Masking: None
  • PrimaryPurpose: Diagnostic

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

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

Intervention / Treatment

  • Procedure: CIPN assessment
  • Other: EV blood analysis

Primary Outcome Measures

  • Change from Baseline in Circulating EV Concentration (11 months from enrollment (T0), to completion of chemotherapy (T2))
    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.

Countries

Italy

Locations and Investigators

  • SC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Recruiting)

Study Officials