A Randomized, Double-Blind, Placebo-Controlled Trial of Omeprazole as A Promising Drug for Protection Against Chemo Induced Neuropathy.

Aya M. Sadek¹*, Sahar K. Hegazy ¹, Zyad M. Hamada ³, Khaled M. Abouelkhair ²

¹Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, El-Gharbia Government, El-Guiesh Street, Tanta 31527, Egypt
²Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Mansoura University, El-Gomhoria Street, Dakahlia 35516, Egypt
³Intern-Faculty of Medicine, Mansoura University, El-Gomhoria Street, Dakahlia 35516, Egypt

ABSTRACT

Background: Patients with gastrointestinal cancers receiving oxaliplatin-fluorouracil chemotherapy protocols are exposed to sensory neuropathy. This study aimed to investigate whether omeprazole can protect from neuropathy in those patients. Methods: This prospective, randomized, double-blinded, placebo-controlled trial included 46 cases with gastrointestinal cancers randomly classified into two equal groups: the control group involving patients received 12 cycles of [Fluorouracil + Leucovorin + Oxaliplatin (FOLFOX4)] with placebo capsules, and the omeprazole (Omepak) group involving patients received 12 cycles of FOLFOX4 plus omeprazole 40 mg orally TID for five days to start two days before each chemotherapy cycle for 6 months. Malonaldehyde, organic cation transporter 2 (OCT2), and neurotensin (NT) were measured at baseline and after three months of treatment initiation. The clinical assessment of neurotoxicity was performed at baseline, 2 weeks after the first cycle, after three months, and at the end of treatment. Results: A significant decrease in the frequency of patients with grade ΙΙ neuropathy in the omeprazole group compared to the control group after three months of intervention (p˂0.001). There was a significant decline in NT and OCT2 levels in the omeprazole group (p=0.004 and p=0.005). The OME group had a lower percentage of individuals with chronic neuropathy (73.91%) in comparison with the control (95.65%), but with no statistically significant difference, however, it has been observed that the appearance of chronic neuropathy tends to be late in the OME group at the 8th cycles. Conclusion: Omeprazole may serve as a promising candidate for drug repositioning to protect against oxaliplatin-induced neuropathy, owing to its safety and efficacy in decreasing oxaliplatin neurotoxicity..

Keywords: Oxaliplatin, Peripheral Neuropathy, Omeprazole, Organic Cation Transporter 2, Neurotensin..

How to cite this article:Sadek AM, Hegazy SK, Hamada ZM, Abouelkhair KM., A Randomized, Double-Blind, Placebo-Controlled Trial of Omeprazole as A Promising Drug for Protection Against Chemo Induced Neuropathy...Int J Drug Deliv Technol. 2026;16(1s): 862-873; DOI: 10.25258/ijddt.16. 862-873