Aspirin may help prevent return of precancerous esophagus condition
NCT ID NCT02521285
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether taking aspirin can prevent Barrett's esophagus from returning after it has been successfully removed with radiofrequency ablation. Researchers will measure levels of a protein linked to Barrett's in tissue samples from 21 participants over 12 months. The goal is to see if aspirin can keep the condition away safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin
- What this could lead to
- If it works, this could point toward a simple, low-cost way to prevent Barrett's esophagus from coming back after treatment.
- What could go wrong
- This is a very small, early-phase trial (21 people) looking at biomarkers, not whether cancer actually develops. Aspirin can cause bleeding, and results may not apply to everyone.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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21 people
The number who actually took part.
- Started
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Jan 2016
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: * Known diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with \>= 1 cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) requiring radiofrequency ablation * Documentation of complete ablation of BE after radiofrequency ablation on two endoscopic examinations at least 3 months apart (including no evidence of BE on surveillance biopsies) as determined by the pathologist at each site; completion of ablation should have occurred no greater than 36 months prior to randomization * The effects of the candidate chemoprevention agents on the developing human fetus remain incompletely defined; for this reason, persons of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a participant become pregnant or suspect she is pregnant while participating in this trial, she should inform the research personnel and her clinical care provider immediately * Willingness to provide tissue samples for research purposes * No chronic use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors during one month prior to randomization; chronic use is defined as any aspirin or NSAID use on \>= 7 days during one month preceding the beginning of randomization * Hemoglobin \>= 10 g/dL or hematocrit \>= 30% (obtained =\< 45 days prior to randomization) * Leukocyte count \>= 3,000/microliter (obtained =\< 45 days prior to randomization) * Platelet count \>= 100,000/microliter (obtained =\< 45 days prior to randomization) * Absolute neutrophil count \>= 1,500/microliter (obtained =\< 45 days prior to randomization) * Creatinine =\< 2.5 x institutional upper limit of normal (ULN) (obtained =\< 45 days prior to randomization) * OR glomerular filtration rate (GFR) \> 30 ml/min/1.73 m\^2 (obtained =\< 45 days prior to randomization) * Total bilirubin =\< 2 x institutional ULN (obtained =\< 45 days prior to randomization) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x institutional ULN (obtained =\< 45 days prior to randomization) * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained =\< 45 days prior to randomization) * A negative serum pregnancy test at baseline, but within 21 days of randomization, for persons of childbearing potential only * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Ability to understand and the willingness to sign a written informed consent document; a legally authorized representative (LAR) may sign informed consent for persons who do not have the capacity to legally consent to take part in the study Exclusion Criteria: * Inability to abstain from, NSAID (including aspirin), and selective COX-2 inhibitor therapy at the time of randomization through the completion of the study (the study period is defined as baseline to exit endoscopy at 18 months after randomization which defines the completion of the study); participants may take Tylenol and non-NSAID pain relievers * Current or planned use of anticoagulant drugs such as: warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox throughout the course of the study * Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 1 month prior to starting aspirin or placebo on this study; consultation with the participant's primary care provider will be obtained prior to stopping any agent; the use of the following drugs or drug classes is prohibited during aspirin/placebo treatment: * NSAIDs: such as aspirin, Naprosyn, ketorolac and others NSAIDs * COX-2 inhibitors: such as celecoxib, rofecoxib * Valproic acid * Sulfinpyrazone * Probenecid * Corticosteroids (other than short-term use defined as less than 2 weeks or pro re nata \[prn (when necessary)\] use of an inhaler less than twice per month) * Platelet aggregation inhibitors, except in a monitored antithrombotic regimen * Methotrexate (MTX) * Vaccines containing live viruses * Gingko * Individuals with uncontrolled renal insufficiency or renal failure * Participants with fundoplication within the past year, bariatric surgery or any other major upper gastrointestinal (GI) surgery; fundoplication more than one year ago will not be grounds for exclusion; cholecystectomy will not be grounds for exclusion * History of invasive cancer diagnosis =\< 12 months prior to randomization, excepting nonmelanoma skin cancer; patients with T1a adenocarcinoma of the esophagus arising in the setting of Barrett's esophagus are eligible for enrollment in the trial * History of cancer treatment =\< 12 months prior to randomization, excepting hormonal therapy (except treatment for non-melanoma skin cancer or carcinoma-in-situ of the cervix) * Receipt of any other investigational agents =\< 3 months prior to randomization, except innocuous agents with no known interaction with the study agents (e.g., standard dose multivitamins or topical agents for limited skin conditions), at the discretion of the protocol lead investigator at each participating site * History of allergic reactions attributed to aspirin or compounds of similar chemical or biologic composition to the study agent * History of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding during the past 5 years or history of endoscopically or radiographically diagnosed peptic ulcer disease with upper GI bleeding any time while taking aspirin * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bleeding disorder, vitamin K deficiency, alcohol abuse (defined as ingestion of 3 or more drinks per day) or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women * Breast feeding women * Surveillance biopsies demonstrating residual BE at qualifying exam * Presence of an esophageal stricture defined as "any recognizable change in esophageal luminal caliber that is accompanied by symptoms of dysphagia, or any asymptomatic narrowing that either will not allow any adult endoscope to pass or allows passage with resistance" * Patients with human immunodeficiency virus (HIV) infection
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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
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
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Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Saint Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
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UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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