Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Intervention: Aspirin; Laboratory Biomarker Analysis; Placebo Administration; Questionnaire Administration
Intervention description: Given PO; Correlative studies; Given PO; Ancillary studies
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies the safety of and how well aspirin works in preventing
      Barrett's esophagus from returning after it has been successfully eliminated by
      radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus
      for the levels of a specific protein that is linked to developing Barrett's esophagus may
      help doctors learn whether aspirin can prevent it from returning after it has been
      successfully treated.
    

Eligibility criteria:

        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