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Heartburn drug may shield cancer patients from nerve pain

NCT ID NCT05680870

Prevention Sponsor: Aya Mohamed Sadek Elsaid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether omeprazole, a common heartburn medication, could prevent nerve damage caused by oxaliplatin chemotherapy in 46 adults with colorectal or pancreatic cancer. Participants took omeprazole before and during chemotherapy cycles. The goal was to see if it reduced acute and chronic peripheral neuropathy symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omeprazole
What this could lead to
If it works, this could offer a simple, low-cost way to prevent painful nerve damage caused by oxaliplatin chemotherapy.
What could go wrong
This is a small, completed phase 3 trial with only 46 participants. Results may not apply to all patients, and omeprazole's protective effect is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

46 people

The number who actually took part.

Started

Feb 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm malignant pancreatic neoplasm pancreatic neoplasm peripheral nervous system disorder chemotherapy-induced neuropathy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy-induced peripheral neuropathy

Contacts and locations

Locations

  • Tanta university

    Tanta, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.