NCT05510856

Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

Detailed description

This is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer. This study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard FOLFOX-4 regimen who will divided into 3 groups: Group 1: 31 Patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months). Group 2: 31 Patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months). Group 3: 31 Patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Conditions

• Oncology

Interventions

Type	Name	Description
OTHER	Duloxetine	Duloxetine 30mg / day for 12 cycles (up to 6 months)
OTHER	Gabapentin	Gabapentin 300 mg / day for 12 cycles (up to 6 months)
OTHER	Lacosamide	Lacosamide 50 mg / day for 12 cycles (up to 6 months)

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-30
• Completion: 2024-10-15
• First posted: 2022-08-22
• Last updated: 2024-11-22

Locations

1 site across 1 country: Egypt