NCT02521285

Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation

Effect of Aspirin on Biomarkers of Barrett's Esophagus After Successful Eradication of Barrett's Esophagus With Radiofrequency Ablation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To conduct a randomized, double blind, placebo-controlled phase II chemoprevention trial, investigating whether supplementation with aspirin 325 mg/day for 12 months is safe and reduces the expression of CDX2 messenger ribonucleic acid (mRNA) (a biomarker which has been associated with the risk of developing Barrett's esophagus \[BE\]) in comparison to placebo after successful radiofrequency ablation (RFA). SECONDARY OBJECTIVES: I. To assess safety at 12 months. II. To assess differences in the expression of CDX2 at 18 months, activation status of NF-kB by assessing levels of total and phosphorylated (phospho)-p65 and cytoplasmic to nuclear translocation of phospho-p65 which is likely to be affected by aspirin. III. To assess the prostanoid marker, prostaglandin E2, and prostaglandin synthases, which are known to respond to aspirin and to correlation with clinicopathological factors in the esophageal cancer. IV. To assess differences in the expression of proinflammatory cytokines known to induce activation of NFkB, i.e., TNFalpha, IL-1beta, IL-6, IL-10, IL-17A, IL-23 will be measured. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive aspirin orally (PO) once daily (QD) for 12 months. ARM B: Patients receive placebo PO QD for 12 months. After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, and 18 months.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-01-15
• Primary completion: 2019-06-18
• Completion: 2026-03-17
• First posted: 2015-08-13
• Last updated: 2025-10-23
• Results posted: 2023-05-01

Locations

10 sites across 2 countries: United States, Canada