International CIPN Assessment and Validation Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- outcome measures for CIPN testing
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov