International Study to Assess and Validate Methods for Evaluating Chemotherapy-Induced Peripheral Neuropathy in Adults

What this Trial Is About

Researchers are investigating chemotherapy-induced peripheral neurotoxicity CIPN in patients receiving neurotoxic chemotherapy drugs in an international, multi-center observational study. The study aims to evaluate how well different assessment methods measure changes in CIPN from before treatment to after treatment, helping define the best tools to assess this condition. It also seeks to understand how mid-treatment assessments can predict outcomes and how patients recover over time, considering different chemotherapy drugs. Participants will undergo a core set of assessments at baseline and end of treatment, including standard oncology evaluations and patient-reported outcome measures like pain scales and neuropathy questionnaires. An extended study phase includes additional tests such as nerve conduction studies, quantitative sensory testing, biomarker analysis, and other specialized questionnaires conducted at multiple time points, including follow-ups up to 24 months after treatment. All participants receive standard chemotherapy the study does not influence treatment or provide medications. During the study, trained investigators will supervise assessments and collect data through questionnaires and clinical scales. The study measures changes in neuropathy symptoms and quality of life using various tools over five to seven years. Data collection includes patient self-reports, clinical evaluations, and biological samples. Follow-up visits help track neurological status and recovery. Participants are expected to complete study-related activities and follow-up visits according to their treatment plan, with data securely uploaded by participating centers.

International CIPN Assessment and Validation Study