NCT05680870CompletedPhase 3
The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients
The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Patients With Cancer Treated With Oxaliplatin-fluorouracil Chemotherapy Protocols
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 28 Dec 2022
- Start date
- 1 Feb 2023
- Primary completion date
- 5 Dec 2024
- Lead sponsor
- Aya Mohamed Sadek Elsaid
- Diseases
- Pancreatic cancer, Colorectal cancer
- NCT number
- NCT05680870
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 46
- From 1 Feb 2023 to the primary completion date, 5 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CRC patients receiving protocols containing capecitabine.
- 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.,).
Other illness
- Evidence of pre-existing peripheral neuropathy resulting from another reason (documented patients with brain tumor, brain trauma, seizures or any other neuropathic disorder).
- Documented Patients with lupus (SLE), or any other autoimmune disease.
- Smokers or documented patients with condition associated with oxidative stress.
Lab values
- 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).
Other
- Diabetic patients.
- Documented Patients with osteoporosis or fractures.
- Pregnant and breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta university Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.