Ireland
--:--IST
Recruiting Observational

Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care

NCT04986891 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-07-31
Last updated
2025-07-29

Condition(s) studied

CIPN

Study summary

This is a pilot, observational, cross-sectional, study on socio-economic burden related to chemotherapy-induced peripheral neurotoxicity (CIPN). Investigators will collect CIPN healthcare related costs on a detailed clinical patient-level. As a sub-study, data obtained in this cross-sectional study, will be compared with administrative larger datasets on patients affected by cancer. The aim is to run a test for potential proxy variables which are available in larger administrative datasets, even if not directly measuring CIPN, to learn more about the impact of CIPN.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Cancer patients with this characteristics: 1. at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy); 2. at least 75 consecutive subjects sent for a neurological evaluation due to stable CIPN condition (CIPN defined as TNSc \> or = 1) after chemotherapy completion (at least 2 months off treatment). 2. Male and female subjects who are 18 years of age or older. 3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry. 4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol. 5. Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria: 1. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments. 2. Severe depression that in the opinion of the Investigator would complicate the assessments. 3. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g., metronidazole, isoniazid, amiodarone, antiretroviral medications). 4. Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes) 5. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.

Primary outcome measure(s)

  • Correlation between Chemotherapy-induced peripheral neurotoxicity (CIPN) as assessed by Total Neuropathy Score (TNSn©) scale and demographic and socio-economic indicators — Baseline
    Correlation between CIPN (as assessed by TNSn© scale) and demographic and socio-economic indicators collected with a questionnaire filled in at screening. The questions included in the questionnaire are drawn from the national sample surveys by the Ministry of Labor and Social Policies (INAPP) and by the Bank of Italy (SHIW).

Trial sites (1)

FacilityCityRegionStatus
ASST Monza Monza Italy Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04986891 on ClinicalTrials.gov ↗ ← All trials in Italy