CompletedPhase 3

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

Egypt46 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 conditi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute peripheral neuropathy

Timeframe: After the first intervention by 2 weeks of the first chemotherapy cycle ( each cycle is two days every two weeks), and through the study average for six months

Chronic peripheral neuropathy

Timeframe: After the end of 12 chemotherapy cycles ( after six months of interventions)

Trial details

NCT IDNCT05680870

SponsorAya Mohamed Sadek Elsaid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-05

View on ClinicalTrials.gov More Chemotherapy Induced Peripheral Neuropathy trials