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

ConditionCIPN

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Milano Bicocca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

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).

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants

are grouped into 2 trial groups

Group A: subjects before first chemotherapy cycle with no neuropathy

Group B: subjects with stable CIPN condition after chemotherapy completion

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milano Bicocca

Lead sponsor

Source ClinicalTrials.gov

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