NCT04986891

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

Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care (CIPN COST) - Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an observational, cross-sectional, pilot study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients, aiming at ascertaining the socio-economic burden related to CIPN. The study will collect the following information: * General medical and oncological history * Neurological assessment formalized via: * NCI-CTC v.5 sensory and motor * PI-NRS * DN4 * TNSc© * Jamar grooved Pegboard test * Patient reported outcome measures related to CIPN: * FACT-GOG NTX v.4© * EORTC CIPN20© * Socio-economic framework: demographic characteristics and working conditions A sub-study is also planned. For this purpose, a comparison with administrative databases, and in particular the data related to cancer patients, will be performed. Unlike the data adopted in the main analysis of the cross-sectional study, the data provided by administrative datasets do not include direct information on CIPN. Investigators will study whether administrative datasets include variables that could be adopted as proxy for CIPN. It will test the reliability of these proxy variables by comparing the expected distribution of CIPN patients in the latter dataset, with the observed distribution in the outpatient dataset - given specific characteristics of the patients. An analysis of this kind would support the activity of policy makers engaged in the treatment of cancer-related problems. Study Design: at least 75 consecutive patients who suffer from CIPN and at least 75 consecutive patients before chemotherapy will be enrolled to gain precise information on CIPN severity and its impact on socio-economic indicators. Subjects will be evaluated once, after obtaining written informed consent. A trained investigator will perform the selected healthcare-assessed scales and supervise the patient-completed measures.

Conditions

• CIPN

Timeline

• Start date: 2021-07-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-08-03
• Last updated: 2025-07-29

Locations

1 site across 1 country: Italy