The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxaliplatin(OXA) chemotherapy protocols are used in treatment of cancers like colorectal (CRC) and pancreatic cancer. OXA causes peripheral neuropathy which is considered treatment limiting factor. In recent studies, it shows that omeprazole(OME) has antioxidant effect and can inhibit organic cation transporter 2 (OCT2) in kidney. So OME can protect against peripheral neuropathy induced by OXA through oxidative stress . Also OME activates extracellular-signal-regulated kinase(ERK) / mitogen activated protein kinase ( MAPK) pathway, so improves demyelinating symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aya Mohamed Sadek Elsaid
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Recently diagnose cases with colorectal (CRC)and pancreatic cancers (males and females) ≥ 18 years old, and ≤ 65 years old.

• Patients who will scheduled to receive modified FOLFOX-4,6,7 (OXA, Leucovorin, and 5-fluorouracil) or mFOLFIRINOX (OXA, irinotecan,leucovorin, and 5-Fluorouracil) for 12 cycles.

• Patients with performance status 0-2 according to Eastern Cooperative Oncology Group (ECOG) Score.

Exclusion Criteria:

• Evidence of pre-existing peripheral neuropathy resulting from another reason (documented patients with brain tumor, brain trauma, seizures or any other neuropathic disorder).

• CRC patients receiving protocols containing capecitabine.

• Diabetic patients.

• Documented Patients with lupus (SLE), or any other autoimmune disease.

• Documented Patients with osteoporosis or fractures.

• Prior exposure to neurotoxic chemotherapy for at least 6 months prior to the study.

• Concomitant use of other neuroprotective medications (gabapentin, lamotrigine, phenytoin, tricyclic antidepressants, etc.,).

• Patients taking medications that omeprazole can interact with or affect their metabolism, such as (digoxin, ketoconazole, methotrexate, clopidogrel, marevan, etc.,).

• Pregnant and breastfeeding women.

• Patients with abnormal renal function (S.cr > 1.5 mg/dl or crcl < 45 ml/min).

• Patients with liver diseases (serum bilirubin > 1.5 mg/dl / Alanine transaminase, Aspartate transaminase > 2-4 ULN).

• Smokers or documented patients with condition associated with oxidative stress.