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

NCT04986891 | Recruiting

• 1 other identifier: CIPN COST
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CIPN

Keywords

chemotherapy; neuropathy; socio-economic indicators; neurotoxicity; CIPN; quality of life

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Secondary Outcomes (6)

• 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

  Baseline

• Correlation between CIPN as assessed by Pain Intensity Numerical Rating Scale (PI-NRS) and demographic and socio-economic indicators

  Baseline

• Correlation between CIPN as assessed by Douleur Neuropathique 4 (DN4) scale and demographic and socio-economic indicators

  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

  Baseline

• Correlation between CIPN as assessed by European Organization for Research and Treatment of Cancer (EORTC) CIPN20© scale and demographic and socio-economic indicators

  Baseline

Other Outcomes (1)

• To investigate whether the larger administrative datasets include variables that could be adopted as proxy for CIPN

  Entire study duration (approximately 8 months)

Study Arms (2)

subjects before first chemotherapy cycle with no neuropathy

at least 75 consecutive subjects sent for an evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);

subjects with stable CIPN condition after chemotherapy completion

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST Monza

Monza, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Central Study Contacts

Paola Alberti, MD

CONTACT

+39 02 6448 8154; paola.alberti@unimib.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 3, 2021
• Study Start: July 31, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

IT (1)