Understanding the socio-economic impact of chemotherapy-induced peripheral neurotoxicity

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

This study looks at how chemotherapy-induced nerve damage affects the everyday lives and costs for cancer patients to better understand its impact.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Monza)
• Trial ID: NCT04986891 on ClinicalTrials.gov

What this trial studies

This observational pilot study focuses on the socio-economic burden associated with chemotherapy-induced peripheral neurotoxicity (CIPN) in cancer patients. It will collect detailed healthcare-related costs and patient assessments, including neurological evaluations and patient-reported outcomes. Additionally, the study aims to compare collected data with larger administrative datasets to identify potential proxy variables for CIPN. This approach seeks to enhance understanding of CIPN's impact on patients and inform policy decisions.

Who should consider this trial

Good fit: Ideal candidates include cancer patients aged 18 and older who are either newly diagnosed or have stable CIPN after chemotherapy.

Not a fit: Patients with concomitant neurological conditions or severe depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the socio-economic challenges faced by patients with CIPN, potentially leading to improved management strategies.

How similar studies have performed: While there have been studies on CIPN, this specific approach of linking socio-economic indicators with CIPN data is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Cancer patients with this characteristics:

   1. at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);
   2. 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).
2. Male and female subjects who are 18 years of age or older.
3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
5. Subjects must have a Karnofsky performance score greater than or equal to 70.

Exclusion Criteria:

1. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
2. Severe depression that in the opinion of the Investigator would complicate the assessments.
3. 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).
4. Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)
5. 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 this trial is running

Monza

• ASST Monza — Monza, Italy (Recruiting)

Study contacts

• Study coordinator: Paola Alberti, MD

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