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Oxaliplatin-induced peripheral neuropathy is one of the most common dose-limiting toxicities of Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) chemotherapy for gastrointestinal cancers, often eliciting treatment interruption and reduced quality of life.
Omeprazole reduces oxaliplatin-induced peripheral neuropathy and delays chronic neurotoxicity in patients receiving FOLFOX4 chemotherapy.
Oxaliplatin-induced peripheral neuropathy is one of the most common dose-limiting toxicities of Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) chemotherapy for gastrointestinal cancers, often eliciting treatment interruption and reduced quality of life. Growing preclinical evidence has suggested that omeprazole possesses neuroprotective properties beyond acid suppression. This study investigated whether omeprazole could prevent or lessen oxaliplatin-induced neuropathy in patients undergoing FOLFOX4 chemotherapy.
This prospective, randomized controlled trial enrolled 46 patients with gastrointestinal cancers. Volunteers were equally assigned to receive either 12 cycles of FOLFOX4 + placebo or FOLFOX4 + omeprazole 40 mg orally three times daily for 5 days, starting 2 days before each chemotherapy cycle, over 6 months. Serum malondialdehyde, organic cation transporter 2 (OCT2), and neurotensin levels were measured at baseline and after 3 months. Clinical neurotoxicity was evaluated at baseline, 2 weeks after the first chemotherapy cycle, 3 months, and at the completion of treatment.
After 3 months, those receiving omeprazole experienced a lower incidence of Grade II peripheral neuropathy than those receiving placebo (p<0.001). Omeprazole use also produced remarkbale reductions in neurotensin (p=0.004) and organic cation transporter 2 levels (p=0.005), indicating a potential modulation of pathways implicated in oxaliplatin neurotoxicity.
Although chronic neuropathy remained common, its incidence was numerically lower in the omeprazole group (73.91% vs. 95.65% with placebo), without attaing statistical significance. Importantly, chronic neuropathy appeared later, typically around the eighth chemotherapy cycle, among those treated with omeprazole, suggesting delayed disease progression.
Omeprazole demonstrated a favorable neuroprotective profile in patients receiving oxaliplatin-based chemotherapy by reducing the severity of peripheral neuropathy, improving neurotoxicity-related biomarkers, and delaying chronic neuropathy onset.
International Journal of Drug Delivery Technology
A Randomized, Double-Blind, Placebo-Controlled Trial of Omeprazole as A Promising Drug for Protection Against Chemo Induced Neuropathy
Aya M. Sadek et al.
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