Evaluation of the Efficacy and Safety of the Addition of Lacosamide to Duloxetine in the Treatment of Taxane-induced Peripheral Neuropathy: A Randomized Double-Blind Placebo-Controlled Trial.

Abstract

Objective: Taxane-induced peripheral neuropathy (TIPN) is a frequent and potentially dose-limiting condition. Despite extensive research, there are still no clear guidelines for treating or preventing TIPN, though recent findings indicate that lacosamide may help relieve acute oxaliplatin-induced neuropathy. Based on this, the present study was conducted to assess the efficacy and safety of combining lacosamide with duloxetine in the treatment of TIPN.

Methods: This randomized, double-blind, placebo-controlled clinical trial enrolled patients undergoing chemotherapy regimens including paclitaxel or docetaxel who developed neuropathy and met predefined inclusion criteria. All participants received duloxetine therapy, initiated at 30 mg per day for the 1^st week and increased to 60 mg daily for the following 11 weeks. In addition, subjects were randomized to receive either lacosamide 200 mg twice daily or a matched placebo. The main outcomes included neuropathy severity assessed at baseline, week 6, and week 12. Data analysis was performed using SPSS version 20, with statistical significance defined as a P < 0.05.

Findings: Both groups showed improvements over time, with reductions in numerical pain rating scale, National Cancer Institute Common Terminology Criteria for Adverse Event, Functional Assessment of Cancer Therapy-Taxane, and Neuropathy Pain Scale scores, and increased scores on the GHS/QoL scale. However, comparisons between the two groups revealed no statistically significant differences at any time point. Similarly, the EORTC QLQ-C30 symptom subscales did not demonstrate significant between-group differences.

Conclusion: This study found that duloxetine alone and its combination with lacosamide both alleviated neuropathic symptoms and improved functional outcomes in patients with TIPN. Nonetheless, the addition of lacosamide did not confer a statistically significant advantage over duloxetine monotherapy.