International CIPN Assessment and Validation Study

Launched by UNIVERSITY OF MILANO BICOCCA · Nov 12, 2020

Keywords

ClinConnect Summary

The International CIPN Assessment and Validation Study is looking at how chemotherapy can cause nerve damage, known as chemotherapy-induced peripheral neuropathy (CIPN). This study aims to collect information from patients who are receiving certain types of chemotherapy that are known to potentially harm nerves. By gathering data from various locations around the world, researchers hope to understand how well specific measures can assess the impact of CIPN on patients' lives.

To be eligible for this study, participants must be at least 18 years old and candidates for chemotherapy that might cause nerve damage. They should be in good health overall, with a performance score indicating they can manage the treatment. Participants will need to agree to follow all study-related activities, which may include regular follow-up visits to monitor their condition. It’s important to note that certain medical conditions or medications may exclude individuals from participating, as they could affect the study's results. This study is actively recruiting participants, and it represents an important step in understanding and improving the quality of life for those affected by CIPN.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
• • 1. Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
• • 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
• Subjects presenting with any of the following will not be included in the study:
• • 1. Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
• • 2. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
• • 3. Severe depression that in the opinion of the Investigator would complicate the assessments.
• • 4. Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
• • 5. Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
• • 6. 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).
• • 7. 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.
• • 8. Previous neurotoxic chemotherapy.