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

NCT05680870 | Completed Phase 3 DMC

• 1 other identifier: MS.22.12.2244.R1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Keywords

Peripheral neuropathy; Colorectal cancer; Pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Acute peripheral neuropathy

  the percentage of patients with acute peripheral sensory neuropathy grade ≥ 2 and the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and pain rating scale score

  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

  Percentage of patients who have developed chronic peripheral neuropathy grade ≥ 2 after the end of 12 cycles and the variation of both NTX-12 total score and pain rating scale

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

Secondary Outcomes (3)

• Malonaldehyde

  After 3 months of treatment

• Neurotensin

  After 3 months of treatment

• OCT

  After 3 months of treatment

Study Arms (2)

Control group

NO INTERVENTION

Control grp will not receive omeprazole . They will receive chemotherapy protocols only

Intervention group

EXPERIMENTAL

Intervention group will receive omeprazole plus chemotherapy protocols

Drug: Omeprazole

Interventions

Omeprazole DRUG

Omeprazole 40 mg 3 times daily for 5 days ..to start 2 days before chemotherapy cycles

Also known as: Omez

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aya Mohamed Sadek Elsaid: lead

Study Sites (1)

Tanta university

Tanta, Egypt

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sahar K Hegazy, Professor

  Professor of clinical pharmacy , faculty of pharmacy, Tanta university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical phatmacist

Model Details: 46 participants will be classified into 2 arms : intervention arm will receive omeprazole plus chemotherapy Control arm will receive chemotherapy only

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 11, 2023
• Study Start: February 1, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 12, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)