RecruitingNCT04633655
International CIPN Assessment and Validation Study
International Chemotherapy Induced Peripheral Neurotoxicity (CIPN) Assessment and Validation Study
Sponsor
University of Milano Bicocca
Enrollment
1,000 participants
Start Date
Jun 8, 2020
Study Type
OBSERVATIONAL
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
Min Age: 18 Years
Inclusion Criteria4
- Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
- Male and female subjects who are 18 years of age or older.
- Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
- Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
Exclusion Criteria9
- Subjects presenting with any of the following will not be included in the study:
- Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
- Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
- Severe depression that in the opinion of the Investigator would complicate the assessments.
- Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
- Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
- 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).
- 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.
- Previous neurotoxic chemotherapy.
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Interventions
OTHERoutcome measures for CIPN testing
questionnaires administration, physician based scales for CIPN data collection
Locations(30)
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NCT04633655