NCT04633655 International CIPN Assessment and Validation Study
| NCT ID | NCT04633655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | Chemotherapy-induced Peripheral Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2020-06-08 |
| Primary Completion | 2025-12-31 |
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 1,000 participants in total. It began in 2020-06-08 with a primary completion date of 2025-12-31.
⚠ 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 an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.
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.
Contact & Investigator
GUIDO CAVALETTI, MD
STUDY CHAIR
University of Milano Bicocca
Frequently Asked Questions
Who can join the NCT04633655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04633655 currently recruiting?
Yes, NCT04633655 is actively recruiting participants. Contact the research team at guido.cavaletti@unimib.it for enrollment information.
Where is the NCT04633655 trial being conducted?
This trial is being conducted at Birmingham, United States, Atlanta, United States, Baltimore, United States, Ann Arbor, United States and 11 additional locations.
Who is sponsoring the NCT04633655 clinical trial?
NCT04633655 is sponsored by University of Milano Bicocca. The principal investigator is GUIDO CAVALETTI, MD at University of Milano Bicocca. The trial plans to enroll 1,000 participants.