International CIPN Assessment and Validation Study (ICAVS)
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.
Objectives
Aims: The primary aim for this study is to test responsiveness of the different assessment methods used in the core study, in a multi-center, multi-regional International setting, comparing changes from baseline to end of treatment. Secondary aims are:
- to evaluate responsiveness (changes from base line to end of treatment) also of the other outcome measures used in the Extended Study;
- to evaluate mid-treatment data predictiveness of end of treatment neurological status for each outcome measure;
- to evaluate recovery rate/modification of the neurological status for the follow up evaluations (3/6/12/24 months after treatment), stratifying data for different drugs.
Eligibility
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- 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.
- 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:
- 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.
Treatment Sites in Georgia
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