Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

Status Not yet recruiting

Clinical Trial Summary

Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.

Clinical Trial Description

The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles. Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4. The primary endpoint of the study is if serum NFL>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy. ;

Study Design

Related Conditions & MeSH terms

Chemotherapy-induced Peripheral Neuropathy
Peripheral Nervous System Diseases

Clinical Trial Details

NCT number	NCT06430814
Study type	Observational
Source	University of Southern Denmark
Contact	Ditte Bork Iversen, MSc Pharm, PhD
Phone	+45 65 50 23 52
Email	dbiversen@health.sdu.dk
Status	Not yet recruiting
Phase
Start date	September 2024
Completion date	September 2026

View Details

See also
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