High Dose Omeprazole for Pancreatic Cancer

(OU202005AJ Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ajay Jain, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Oklahoma

Disqualifiers: Neuroendocrine tumors, Pregnancy, Cardiac, others

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety of high dose omeprazole and see what effects that it has on patients with exocrine pancreatic cancer.

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.

What data supports the effectiveness of the drug Omeprazole for pancreatic cancer?

Research suggests that Omeprazole may help inhibit the growth of pancreatic cancer cells and modulate their resistance to chemotherapy. Additionally, Omeprazole has shown anti-cancer properties in colon cancer studies, which might indicate potential benefits for pancreatic cancer as well. ^{1 2 3 4 5}

Is high dose omeprazole generally safe for humans?

Omeprazole has been used safely in many people for conditions like ulcers and acid reflux, with common mild side effects like headache, dizziness, and nausea. Serious side effects are rare, and it has been well tolerated even in long-term use for conditions like Zollinger-Ellison syndrome. ^{1 6 7 8 9}

How does the drug omeprazole differ from other treatments for pancreatic cancer?

Omeprazole is unique in treating pancreatic cancer because it may help reduce tumor resistance to chemotherapy by affecting the cancer cells' growth and survival mechanisms. This is different from traditional treatments that primarily focus on directly killing cancer cells. ^{1 7 10 11 12}

Research Team

Ajay Jain, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

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.

I do not have any serious heart problems that could affect my safety or the study results.

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

Trial Timeline

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

Treatment Details

Interventions

• Omeprazole (Proton Pump Inhibitor)

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.

Participant Groups

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

Omeprazole, 80 mg, PO, BID for 2 weeks 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 2 weeks prior to surgical therapy of pancreatectomy.

Omeprazole is already approved in Canada, Japan, China, Switzerland for the following indications:

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+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Omeprazole inhibits proliferation and modulates autophagy in pancreatic cancer cells. [2023]

2. Greece 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. [2018]

3. Greece 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. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Role of proton pump inhibitor on esophageal carcinogenesis and pancreatic acinar cell metaplasia development: an experimental in vivo study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Proton-pump inhibitor as palliative care for chemotherapy-induced gastroesophageal reflux disease in pancreatic cancer patients. [2022]

6. France 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]. [2013]

7. New Zealand 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. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The clinical safety of omeprazole. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Omeprazole: a novel antisecretory agent for the treatment of acid-peptic disorders. [2019]

10. India pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

Omeprazole in the treatment of Zollinger-Ellison syndrome: a 4-year international study. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Effects of single and repeated doses of omeprazole on gastric acid and pepsin secretion in man. [2022]