An observational study in CIPN, sponsored by University of Milano Bicocca. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by University of Milano Bicocca · Observational
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.
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:
Neurological assessment formalized via:
Patient reported outcome measures related to CIPN:
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.
137 studies on the registry are indexed under Neurotoxicity Syndromes; 16 are open to participants now.
This study's planned enrollment of 150 is above the median of 86 across 38 observational studies indexed under Neurotoxicity Syndromes.
Browse Neurotoxicity Syndromes studies →University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cancer patients (at least 18 years old) as follows. Group A: at least 75 consecutive subjects sent for an evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy); Group B: at least 75 consecutive subjects sent for an evaluation due to stable CIPN condition (CIPN defined as TNSc > or = 1) after chemotherapy completion (at least 2 months off treatment).
Cancer patients with this characteristics:
Exclusion Criteria:
at least 75 consecutive subjects sent for an evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);
subjects sent for an evaluation due to stable CIPN condition (CIPN defined as TNSc \> or = 1) after chemotherapy completion (at least 2 months off treatment).
Correlation between Chemotherapy-induced peripheral neurotoxicity (CIPN) as assessed by Total Neuropathy Score (TNSn©) scale and demographic and socio-economic indicators
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).
Time frame: Baseline
Correlation between CIPN as assessed by National Cancer Institute-Common Toxicity Criteria (NCI-CTC v. 5) sensory and motor grade and demographic and socio-economic indicators
Correlation between CIPN assessed by NCI-CTC v.5 sensory and motor questionnaire (0-5 score. where 5 means worse outcome) and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
Correlation between CIPN as assessed by Pain Intensity Numerical Rating Scale (PI-NRS) and demographic and socio-economic indicators
Correlation between CIPN assessed by PI-NRS scale (0-10 score, where 10 means worse outcome) and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
Correlation between CIPN as assessed by Douleur Neuropathique 4 (DN4) scale and demographic and socio-economic indicators
Correlation between CIPN assessed by DN4 scale (0-10 score, where 10 means worse outcome) and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
Correlation between CIPN as assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 (FACT-GOG NTX v.4©) scale and demographic and socio-economic indicators
Correlation between CIPN assessed by FACT-GOG NTX v.4© scale (0-44 score, where 44 means worse outcome) and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
Correlation between CIPN as assessed by European Organization for Research and Treatment of Cancer (EORTC) CIPN20© scale and demographic and socio-economic indicators
Correlation between CIPN assessed by EORTC CIPN20© scale (0-100 score, where 100 means worse outcome) and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
Correlation between CIPN as assessed by Jamar grooved Pegboard test and demographic and socio-economic indicators
Correlation between CIPN assessed by Jamar grooved Pegboard test and demographic and socio-economic indicators collected with a questionnaire filled in at screening.
Time frame: Baseline
To investigate whether the larger administrative datasets include variables that could be adopted as proxy for CIPN
Reliability of these proxy variables will be tested by comparing the expected distribution of CIPN patients, in the administrative datasets, with the observed distribution in the cross-sectional study.
Time frame: Entire study duration (approximately 8 months)
Plan to share: Undecided
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University of Milano Bicocca