Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care
Launched by UNIVERSITY OF MILANO BICOCCA · Jul 26, 2021
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a condition called chemotherapy-induced peripheral neurotoxicity (CIPN), which can cause nerve damage and discomfort in cancer patients after they receive chemotherapy. The researchers want to understand the financial and health impacts of CIPN by collecting detailed information about healthcare costs and comparing it with larger datasets of cancer patients. This will help them identify factors that could indicate the presence of CIPN, even if they aren't directly measuring it.
To participate in this study, you need to be an adult over 18 years old and either have no nerve damage before starting chemotherapy or have stable nerve damage after completing treatment. Participants will need to agree to complete study-related activities and follow-up visits. It's important to note that individuals with certain neurological conditions or other health issues that could interfere with the study won't be eligible. If you choose to take part, you'll help researchers learn more about the challenges faced by cancer patients experiencing CIPN, which could lead to better support and treatment in the future.
Gender
ALL
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.
About University Of Milano Bicocca
The University of Milano-Bicocca is a distinguished academic institution renowned for its commitment to advancing research and education in the biomedical sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials that aim to enhance patient care and medical outcomes. Its research initiatives are supported by state-of-the-art facilities and a dedicated team of experts, positioning the University of Milano-Bicocca as a leading sponsor in the realm of clinical trials, dedicated to translating scientific discoveries into practical applications for the benefit of society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Monza, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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