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โ† Trials
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International CIPN Assessment and Validation Study

Recruitingn/aAges 18 Years - anyAllUniversity of Milano Bicocca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • outcome measures for CIPN testing
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Where

30 sites
Birmingham School of Nursing, University of Alabama
Birmingham, United States
Northside Hospital
Atlanta, United States
JHU
Baltimore, United States
University of Michigan School of Nursing
Ann Arbor, United States
Columbia University Irving Medical Center
New York, United States
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division
Columbus, United States
Dartmouth-Hitchcock Medical Center
Lebanon, United States
University of Vermont Medical Center
Burlington, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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