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

Recruiting now

Conditions studied: CIPN

In brief

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.

Key facts

Study ID

NCT04986891

Run by

University of Milano Bicocca

People needed

150

Starts

2021-07-31

Expected to finish

2025-12-01

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cancer patients with this characteristics:
• at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);
• 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).
• Male and female subjects who are 18 years of age or older.
• Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
• Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
• Subjects must have a Karnofsky performance score greater than or equal to 70.

You may not qualify if…

• Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
• Severe depression that in the opinion of the Investigator would complicate the assessments.
• 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).
• Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)
• 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.

Where it is running

• ASST Monza — Monza, Italy (enrolling)

Full record on ClinicalTrials.gov

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