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Sponsor: Paracelsus Medical University
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Interventions: Questionnaire and Physical Exam
Countries: Austria
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, comprehensive functional assessments will be conduicted and the results will be corrleated with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading . In addition, data from matched healthy controls and chemotherapy patients without CIPN 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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: OBSERVATIONAL
Inclusion Criteria: \- Male and female patients with CIPN grade ≥ 2, according to Common Terminology Criteria for Adverse Events for peripheral sensory or motor neuropathy (CTCAE) version 5 \- Age ≥ 18 \- Ongoing or completed neuropathy-inducing chemotherapy \- Ability to stand and walk \- Ability to fill out a questionnaire Inclusion criteria for healthy controls \- Male and female adults (age ≥ 18) \- Ability to stand and walk \- Ability to fill out a questionnaire Exclusion Criteria: * Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) Acute or chronic injuries/ diseases of the musculoskeletal system affecting functional tests \- Acute or chronic cardiovascular diseases affecting functional tests \- Neurological disease affecting functional tests (for healthy controls) \- Neurological disease other than CIPN affecting functional tests (for CIPN patients)
- Salzburg, Austria