High Dose Omeprazole for Pancreatic Cancer

(OU202005AJ Trial)

Overseen By Ingrid Block

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Disqualifiers: Neuroendocrine tumors, Pregnancy, Cardiac, others

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called omeprazole, a proton pump inhibitor, to determine its safety and effects on individuals with exocrine pancreatic cancer. The study includes two groups: one receiving a high dose and the other a normal dose. It targets individuals recently diagnosed with this cancer who plan to undergo surgery to remove the tumor. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially beneficial treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high doses of omeprazole, a proton pump inhibitor (PPI), might slightly increase the risk of pancreatic cancer. However, other studies have found that using PPIs generally does not significantly raise this risk. While there is some concern about high doses, the overall risk remains low based on current evidence.

PPIs are usually well-tolerated by most people, with common side effects like headache, stomach pain, or nausea, which are typically mild. This study focuses on how well patients can tolerate a higher dose of omeprazole.

As an early-stage study, the main goal is to assess the safety of using a high dose of omeprazole in people with pancreatic cancer. Specific safety data for these high doses in this group is limited, so the trial aims to gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about high-dose Omeprazole for pancreatic cancer because it could offer a new approach to supporting patients undergoing pancreatectomy. Unlike standard chemotherapy or radiation therapies that directly target cancer cells, high-dose Omeprazole, typically used for reducing stomach acid, might enhance the body's environment to make surgical treatment more effective. This high-dose regimen is unique because it is administered in significant quantities (80 mg twice daily) for a short period before surgery, potentially optimizing surgical outcomes without the harsh side effects of conventional treatments. These features make it a promising candidate for improving recovery and treatment success in pancreatic cancer patients.

What evidence suggests that high dose omeprazole might be an effective treatment for pancreatic cancer?

This trial investigates how omeprazole, a proton pump inhibitor (PPI), might affect pancreatic cancer. Participants will be divided into two groups: Arm A will receive a high dose of omeprazole (80 mg, twice daily), and Arm B will receive a normal dose (20 mg, once daily) for 12-14 days before undergoing pancreatectomy. Some studies have shown that high doses of PPIs could increase the risk of developing pancreatic cancer, with regular use linked to a 75% higher risk. Although this might sound concerning, the study of omeprazole for treating existing pancreatic cancer differs. Researchers are exploring whether higher doses could help fight the cancer, but this research remains in the early stages. ^{1 2 5 6 7}

Who Is on the Research Team?

Ajay Jain, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with a specific type of pancreatic cancer known as exocrine adenocarcinoma, who are fit enough for surgery. They must not be pregnant or breastfeeding and should have no major heart issues or conditions that affect medication absorption. A negative pregnancy test is required for women able to bear children.

Inclusion Criteria

Ability to provide written informed consent and HIPAA authorization

My organs are healthy enough for surgery.

I have been newly diagnosed with a specific type of pancreatic cancer.

Exclusion Criteria

You have any other important abnormal lab results that could affect your safety or the study results.

My pancreatic tumor is confirmed as a neuroendocrine or another type of cancer.

Positive pregnancy test, pregnant, or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high dose omeprazole treatment for 14 days prior to surgical therapy

2-3 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omeprazole

Trial Overview The study aims to evaluate the safety and effects of high doses of Omeprazole in patients with exocrine pancreatic cancer. It will involve participants who may or may not have received chemotherapy before joining the trial.

How Is the Trial Designed?

Group I: Arm A (High Dose) Experimental Treatment 1 Intervention

Omeprazole, 80 mg, PO, BID for 12-14 days prior to surgical therapy of pancreatectomy. All 30 subjects in Arm A to be enrolled prior to Arm B cohort enrollment.

Group II: Arm B (Normal Dose) Placebo Group 1 Intervention

Omeprazole, 20 mg, PO, QD for 12-14 days prior to surgical therapy of pancreatectomy.

Omeprazole is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Losec for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in United States as Prilosec for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in Canada as Omez for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in Japan as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in China as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Approved in Switzerland as Omeprazole for:

• Gastroesophageal reflux disease (GERD)
• Peptic ulcer disease
• Zollinger-Ellison syndrome

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

Omeprazole, an H+, K(+)-ATPase inhibitor, effectively reduced acid secretion in over 90% of 80 patients with Zollinger-Ellison syndrome, achieving desired levels of less than 10 mmol/hour and providing rapid symptom relief.

The treatment was well-tolerated with minimal adverse effects, and no evidence of tachyphylaxis was observed, making omeprazole a safe and effective alternative to more invasive procedures like total gastrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omeprazole in the treatment of Zollinger-Ellison syndrome: a 4-year international study. Lloyd-Davies, KA., Rutgersson, K., Sölvell, L.[2019]

In a study involving twelve healthy subjects, omeprazole significantly reduced gastric acid secretion, achieving up to 95.3% reduction in stimulated acid output after a single 60 mg dose.

Omeprazole effectively inhibited acid production almost completely after seven days of daily treatment, while not affecting pepsin secretion, indicating its specific action on the H+/K+-ATPase enzyme without notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of single and repeated doses of omeprazole on gastric acid and pepsin secretion in man. Howden, CW., Forrest, JA., Reid, JL.[2022]

In a study of 137 patients with chronic pancreatitis, those treated with high-dose omeprazole experienced significantly better pain relief (96.96%) compared to the control group (68.1%) after 2 weeks.

The omeprazole group also showed greater weight gain (95%) over one year compared to the control group (69.5%), with no reported side effects, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Pain Relief in Chronic Pancreatitis: an Old Drug in a New Pack: a Controlled Study. Pujahari, AK.[2019]

A review of over 19,000 individuals showed that omeprazole has a low incidence of mild and transient adverse events, such as nausea and headache, which typically do not require dose adjustments or discontinuation of therapy.

No serious drug-related adverse events were found in patients with renal insufficiency or severe liver failure, and long-term use of omeprazole did not lead to significant histological changes in gastric cells, indicating its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical safety of omeprazole. Sölvell, L.[2018]

Omeprazole, a proton pump inhibitor used since 1989 for treating peptic ulcers and other conditions, has been found to be well tolerated in most clinical trials, with adverse effects occurring in approximately 1 in 12,200 treatments over 4 weeks.

While the drug is generally safe, some reported adverse reactions include neurological issues like confusion (especially in older patients or those with liver disease), skin rashes, and potential hematological effects, prompting health authorities to inform prescribers about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months]. Castot, A., Bidault, I., Dahan, R., et al.[2013]

Omeprazole is a proton pump inhibitor that effectively reduces gastric acid secretion, making it useful for treating conditions like gastric ulcers and gastroesophageal reflux disease, with clinical trials showing it is at least as effective as other treatments.

Despite its short half-life of 1-2 hours, omeprazole has a prolonged effect on reducing stomach acidity, and it has minimal adverse reactions, leading to its FDA approval for both short-term and long-term use in specific gastrointestinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omeprazole: a novel antisecretory agent for the treatment of acid-peptic disorders. Lampkin, TA., Ouellet, D., Hak, LJ., et al.[2019]

Chronic treatment with omeprazole, a proton pump inhibitor, improved healing of esophageal ulcerative lesions in a study of 115 rats, but did not affect overall mortality or the incidence of pre-neoplastic lesions.

However, the study found that PPI-treated rats had a higher occurrence of locally invasive neoplastic lesions and gastric pancreatic acinar cell metaplasia compared to the placebo group, suggesting potential risks associated with long-term PPI use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of proton pump inhibitor on esophageal carcinogenesis and pancreatic acinar cell metaplasia development: an experimental in vivo study. Dall'Olmo, L., Fassan, M., Dassie, E., et al.[2018]

Omeprazole has been shown to inhibit the proliferation of pancreatic cancer cell lines at likely non-toxic concentrations, suggesting it could be a potential adjunct therapy to enhance the effectiveness of chemotherapy drugs like 5-fluorouracil and gemcitabine.

The study indicates that omeprazole modulates lysosomal transport and autophagy pathways in pancreatic cancer cells, leading to programmed cell death, which may help overcome the common chemoresistance seen in these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omeprazole inhibits proliferation and modulates autophagy in pancreatic cancer cells. Udelnow, A., Kreyes, A., Ellinger, S., et al.[2023]

In a study of pancreatic cancer patients undergoing chemotherapy with gemcitabine or S-1, 40% experienced gastroesophageal reflux disease (GERD) as a side effect.

Treatment with sodium rabeprazole, a proton-pump inhibitor, significantly improved GERD symptoms in these patients, highlighting its potential as an effective intervention for managing chemotherapy-induced GERD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton-pump inhibitor as palliative care for chemotherapy-induced gastroesophageal reflux disease in pancreatic cancer patients. Uwagawa, T., Misawa, T., Iida, T., et al.[2022]

In a study of 42 patients who underwent pylorus-preserving pancreatico-duodenectomy (PPPD), those who received Omeprazole (a proton pump inhibitor) had significantly lower gastric juice volume and acidity compared to the control group that received saline.

The results suggest that administering Omeprazole post-surgery effectively reduces gastric secretion, which may help prevent complications such as gastric bleeding and excessive gastric juice production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of omeprazole, a proton pump inhibitor, on early gastric stagnation after a pylorus-preserving pancreaticoduodenectomy: results of a randomized study. Toyota, N., Takada, T., Yasuda, H., et al.[2018]

Omeprazole is a highly effective medication for healing duodenal ulcers, achieving healing rates of 60-100% after 2 weeks and 90-100% after 4 weeks, even in patients who did not respond to other treatments like H2-receptor antagonists.

Despite some concerns from animal studies about potential risks of carcinoid tumors, preliminary studies in humans have shown no significant mucosal changes at therapeutic doses, suggesting that omeprazole is safe for treating peptic ulcer disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omeprazole. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in peptic ulcer disease and Zollinger-Ellison syndrome. Clissold, SP., Campoli-Richards, DM.[2018]

In a study with male F344 rats, omeprazole significantly reduced the formation of colonic aberrant crypt foci (ACF) by approximately 30%, indicating its potential as a chemopreventive agent against colon cancer.

In human colon cancer cell lines, omeprazole induced the expression of the tumor suppressor protein p21 and decreased levels of anti-apoptotic proteins, suggesting that it may inhibit cancer cell growth and promote apoptosis in a dose-dependent manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-carcinogenic properties of omeprazole against human colon cancer cells and azoxymethane-induced colonic aberrant crypt foci formation in rats. Patlolla, JM., Zhang, Y., Li, Q., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9381101/

Use of Proton Pump Inhibitors and Risk of Pancreatic Cancer On the basis of these findings, a slight increase in the risk of pancreatic cancers associated with the use of PPIs at high cumulative doses cannot be excluded.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7463819/

Does the Use of Proton Pump Inhibitors Increase the Risk of ... Considering the carcinogenic effect of PPIs on cancer, the risk of pancreatic cancer could be increased when using high-dose or long-term PPIs.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04930991

High Dose Omeprazole in Patients With Pancreatic Cancer Study Details | NCT04930991 | High Dose Omeprazole in Patients With Pancreatic Cancer | ClinicalTrials.gov.

4. mdpi.com mdpi.com/2072-6694/14/21/5357

Proton Pump Inhibitors Use and the Risk of Pancreatic ... The findings of their study showed that PPI use was associated with a 75% increased risk of pancreatic cancer (pooled RR, 1.75 95%CI: 1.12–2.72), with high ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1673200/full

Proton pump inhibitor use and pancreatic risk Results: In primary analyses, regular PPI use showed a time-dependent association with acute pancreatitis. However, this association was not robust: multiple ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-12551

High-Dose Omeprazole for the Treatment of Patients with ... This trial may help doctors see what effects (good and bad) that high-dose omeprazole has on patients with pancreatic cancer. Eligibility Criteria. Inclusion ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012754/

Proton Pump Inhibitors and Cancer Risk - PubMed Central - NIH The study showed that PPI use was not significantly associated with the risk of pancreatic cancer (1.08-fold), based on the duration of use, ...