Aspirin for Barrett's Esophagus

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byRobert S Bresalier

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

This trial is for people who've had Barrett's Esophagus treated with radiofrequency ablation. They must not have used aspirin or similar drugs recently, agree to use contraception, and have normal blood counts and organ function. Excluded are those on anticoagulants, certain other medications, recent cancer treatments (except non-melanoma skin cancer), uncontrolled illnesses, pregnant or breastfeeding women, and those with HIV.

Inclusion Criteria

My Barrett's esophagus was completely treated with radiofrequency ablation, confirmed by two exams.

Ability to understand and sign a written informed consent document

I haven't taken aspirin, NSAIDs, or COX-2 inhibitors in the last month.

See 6 more

Exclusion Criteria

Receipt of other investigational agents

Pregnant or breastfeeding women

I have been recently diagnosed or treated for cancer.

See 11 more

Treatment Details

Interventions

Aspirin (Nonsteroidal Anti-inflammatory Drug)

Trial OverviewThe study tests if aspirin can prevent the recurrence of Barrett's Esophagus after successful treatment. Participants will be randomly given either aspirin or a placebo while researchers monitor protein levels in tissue samples to assess effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (aspirin)Experimental Treatment3 Interventions

Patients receive aspirin PO QD for 12 months.

Group II: Arm B (placebo)Placebo Group3 Interventions

Patients receive placebo PO QD for 12 months.