A pill that could block stomach cancer before it starts
NCT ID NCT02794428
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers are testing whether a drug called eflornithine can reduce DNA damage in stomach cells that have precancerous changes. The trial enrolls adults aged 30 to 60 with atrophic gastritis or intestinal metaplasia, conditions that raise stomach cancer risk. Participants take eflornithine or a placebo daily for 18 months. The study measures changes in stomach cell DNA damage at 6 and 18 months to see if the drug lowers cancer risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eflornithine (DFMO), an oral drug taken daily for 18 months
- What this could lead to
- If it works, this could lead to a way to prevent stomach cancer in people with precancerous stomach changes.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so the drug may not prove effective. Eflornithine can cause hearing changes, so participants need hearing tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
91 people
The number who actually took part.
- Started
-
Sep 2016
- Finished
-
Jul 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
-
30 to 69 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 Hide 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: * Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia * Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization. * Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days): * Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL * Kidney function: Creatinine \<1.6 x IULN (institutional upper limit of normal) * Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN Exclusion Criteria: * Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation * Patients must not have a significant medical or psychiatric condition that would preclude study completion. * Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible. * Patients must not have known hypersensitivity to eflornithine or the excipients. * Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis. * Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP \> 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV). * Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease. * No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for \>5 years. * Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis. * Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ministry of Health, Hospital de Occidente
Copán, Honduras
-
University of Puerto Rico, Comprehensive Cancer Center
San Juan, Puerto Rico
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