University of Milano Bicocca
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.
The study will be performed at all participating centers and will consist of the following assessments: Core study (assessments at baseline and at the end of treatment) * Standard oncology assessment per local site * NCI-CTC (national cancer institute common toxicity criteria) v.5 sensory and motor * PRO-CTCAE (patient reported outcome-cancer common tocixity adverse event) * PI-NRS (pain intensity numeric rating scale) * NPS-CIN (Neuropathic Pain Scale for chemotherapy-induced neuropathy) * EORTC CIPN20© (The European Organisation of Research and Treatment of. Cancer Quality of Life Question…
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…
questionnaires administration, physician based scales for CIPN data collection