NCT04986891 Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care
| NCT ID | NCT04986891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | CIPN |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-07-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-07-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04986891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CIPN. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04986891 currently recruiting?
Yes, NCT04986891 is actively recruiting participants. Contact the research team at paola.alberti@unimib.it for enrollment information.
Where is the NCT04986891 trial being conducted?
This trial is being conducted at Monza, Italy.
Who is sponsoring the NCT04986891 clinical trial?
NCT04986891 is sponsored by University of Milano Bicocca. The trial plans to enroll 150 participants.