Clinical Trial

Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy

Study acronym: Assess CIPN
Not Yet Recruiting
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Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side effect of several anti-cancer agents. Typical symptoms include tingling and hypoesthesia in the fingertips and/or toes, which substantially impair patients' quality of life and independence. Providing effective, evidence-based treatments for CIPN remains a major challenge in clinical practice. In a recent randomized clinical trial, our group demonstrated the effectiveness of electrotherapy in reducing both sensory and motor symptoms, as assessed by the EORTC-QLQ-CIPN20 questionnaire and CIPN grading according to CTCAE. However, these findings were based exclusively on patients' subjective self-reports (EORTC QLQ CIPN 20 and C-30). To more objectively evaluate treatment success, functional assessments that capture impairments in daily activities are needed. In this cross-sectional comparison, we will conduct comprehensive functional assessments and correlate the results with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading. In addition, data from matched healthy controls will be collected and compared with those of CIPN patients. The findings of this study will contribute to the development of objective measures of functional limitations caused by CIPN and provide a valuable complement to patient-reported outcome obtained through validated questionnaires.
Trial Details
NCT Number NCT07315334
Lead Sponsor Paracelsus Medical University
Collaborators: General Hospital Nuremberg & Paracelsus Medical University Nuremberg
Conditions Chemotherapy Induced Peripheral Neuropathy (CIPN)
Enrollment 80 participants
Start Date 2026-01-15
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-02