About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.)
Trial population
CIPN patients from the paracleus medical university Healthy matched controls
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Questionnaire and Physical Exam
Diagnostic testMeasurements: EORTC QLQ-CIPN 20 questionnaire, short physical performance test battery, gait and balance, 9 hole peg test, grip strength
Treatment groups
Trial outcomes
Primary outcomes
correlation between questionnaire data abd functional assessments
correlation between questionnaire data abd functional assessments
Correlations between questionnaire data and functional assessments
Secondary outcomes
Group differences in functional assessments between CIPN patients and helathy controls
Group differences in functional assessments between CIPN patients and helathy controls
Sponsors and contacts
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