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High Dose Omeprazole in Patients With Pancreatic Cancer

Recruiting
18 - 99 years of age
Both
Phase N/A

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Overview

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.

Description

During this study patients will receive treatment of omeprazole at the dose depending on group enrollment

  • Group A will receive omeprazole 80 mg, twice a day for 14 days unless unacceptable toxicity
  • Group B, will receive omeprazole 20 mg, once a day for 14 days

Patients will receive treatment for 2~3 weeks during the study, and 2 months of follow up.

Total accrual is anticipated to take 2 years.

Eligibility

Inclusion Criteria:

  • Newly diagnosed exocrine pancreatic cancer with pathology confirmed as adenocarcinoma
  • Patient is a candidate for surgical resection of pancreatic cancer
  • ≥ 18 years old at the time of informed consent
  • ECOG Performance Status 0-2
  • Patients with or without neoadjuvant chemotherapy will be eligible
  • Ability to provide written informed consent and HIPAA authorization
  • Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration. All women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria:
  • Prior hysterectomy or bilateral oophorectomy;
  • Has not had menses at any time in the preceding 24 consecutive months
  • Adequate organ function for surgical therapy

Exclusion Criteria:

  • Patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies
  • Positive pregnancy test, pregnant, or breastfeeding
  • Known hypersensitivity to any component of the formulation or substituted benzimidazoles
  • Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study
  • Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
  • Medical condition that might affect the absorption of study medications in the opinion of the investigator.

Study details

Exocrine Pancreatic Cancer

NCT04930991

University of Oklahoma

22 February 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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