NCT06430814

Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 188 (estimated)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2024-10-10
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-05-28
• Last updated: 2025-09-02

Locations

3 sites across 1 country: Denmark