C50 C56
Conditions
Interventions
Group 1: Monocentric prospective cohort study conducted at the University Medical Center Mainz with three assessment time points: T0 = before initiation of taxane therapy (baseline), T1 = before cycle
patients with pre-existing acute PNP are excluded.
The aim of the study is to determine whether standard methods (clinical examination, nerve conduction studies, quantitative sensory testing, QST) and
Sponsors
Klinik und Poliklinik für Neurologie
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Ovarian or breast cancer with planned taxane-based chemotherapy
Exclusion criteria
Exclusion criteria: Inflammatory diseases of the central nervous system, history of acute vascular events (hemorrhage/ischemia), acute polyneuropathy, neurodegenerative disorders, prior treatment with taxanes, or impaired capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of our study is the occurrence of CIPN at T2 (4 weeks after completion of therapy), defined as a Toronto Clinical Neuropathy Score (TCNS) = 6 in participants who had a TCNS = 5 at T0. | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Standard methods (objectification & function) - Nerve conduction studies (NCS): considered pathological at T2 (vs. T0) if the amplitude of = 1 nerve falls below the laboratory lower limit of normal (LLN). - Quantitative sensory testing (QST, DFNS): z-scores for thermal and pain thresholds; abnormality defined as |z| > 1.96; change from T0 to T2 analyzed. - Clinical examination, Timed Up and Go (TUG), and 9-Hole Peg Test (9HPT, bilateral). B) Biomarkers - NfL, peripherin, GFAP (T0/T1): prediction of CIPN? status at T2 using ROC/AUC analysis; cut-offs determined by the Youden index (sensitivity/specificity, 95 % CI). - ?-analyses (T0 ? T2) and correlation with TCNS. | — |
Countries
Germany
Contacts
Public ContactFrank Birklein
Klinik und Poliklinik für Neurologie
Outcome results
None listed