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Aspirin for Barrett's Esophagus

Q: What has the FDA's stance been on Aspirin in recent years?

Aspirin's safety is only supported by Phase 2 data, meaning that while there are some studies suggesting it is safe, none of them confirm that it is effective. Our team at Power gave it a score of 2.

Q: What is the history of research surrounding Aspirin?

Clinical trials studying aspirin began in 2002 at Institut Curie Hopital. To date, 1206 have been completed with 180 more currently underway. Many of the ongoing studies are based out of <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>.

Q: What type of patient would be best suited for this clinical trial?

This clinical trial is looking for 23 patients who have been diagnosed with barrett esophagus and are between 18-75 years old. Key inclusion criteria are as follows: A known diagnosis of BE which requires radiofrequency ablation, Documentation that BE has been completely ablated after two endoscopic examinations that were 3 months apart (as determined by a pathologist), Be willing to provide tissue samples, Not currently using aspirin or NSAIDs chronically (defined as 7 or more days in one month), Hemoglobin >= 10 g/dL, Leukocyte count >= 3,000/microliter, Platelet count >= 100,000/microliter

Phase 2

Waitlist Available

Led By Robert S Bresalier

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known diagnosis of histologically-confirmed BE with or without dysplasia requiring radiofrequency ablation

ECOG performance status =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Study Summary

This trial studies aspirin to prevent Barrett's esophagus from returning after it has been treated. Samples of tissue will be studied for a protein linked to developing Barrett's esophagus.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects include digestive issues like stomach ulcers or bleeding (especially if there’s a history of peptic ulcer disease), allergic reactions to aspirin-like substances, increased risk of bleeding due to its blood-thinning properties, and possibly liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Barrett's esophagus diagnosed through a biopsy, needing radiofrequency ablation.

Select...

I can take care of myself and do some of my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B)

+3 more

Secondary outcome measures

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C)

+19 more

Other outcome measures

Differences in the Expression of Proinflammatory Cytokines Known to Induce Activation of NFkB

Differences in the Prostanoid Marker, Prostaglandin E2, and Prostaglandin Synthases

Incidence of Barrett's Esophagus (BE) Recurrence

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetylsalicylic acid

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,132 Total Patients Enrolled

Robert S BresalierPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Aspirin Clinical Trial Eligibility Overview. Trial Name: NCT02521285 — Phase 2

Barrett's Esophagus Research Study Groups: Arm A (aspirin), Arm B (placebo)

Barrett's Esophagus Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT02521285 — Phase 2

Aspirin 2023 Treatment Timeline for Medical Study. Trial Name: NCT02521285 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has the FDA's stance been on Aspirin in recent years?

"Aspirin's safety is only supported by Phase 2 data, meaning that while there are some studies suggesting it is safe, none of them confirm that it is effective. Our team at Power gave it a score of 2."

Answered by AI

What is the history of research surrounding Aspirin?

"Clinical trials studying aspirin began in 2002 at Institut Curie Hopital. To date, 1206 have been completed with 180 more currently underway. Many of the ongoing studies are based out of Kansas City, Missouri."

Answered by AI

What type of patient would be best suited for this clinical trial?

"This clinical trial is looking for 23 patients who have been diagnosed with barrett esophagus and are between 18-75 years old. Key inclusion criteria are as follows: A known diagnosis of BE which requires radiofrequency ablation, Documentation that BE has been completely ablated after two endoscopic examinations that were 3 months apart (as determined by a pathologist), Be willing to provide tissue samples, Not currently using aspirin or NSAIDs chronically (defined as 7 or more days in one month), Hemoglobin >= 10 g/dL, Leukocyte count >= 3,000/microliter, Platelet count >= 100,000/microliter"

Answered by AI

Does this research break new ground in the medical field?

"At the moment, there are 180 ongoing studies for Aspirin being conducted in 61 countries and 1450 cities. The first study was completed 18 years ago in 2002 by 413 participants. Since then, 1206 more have been completed."

Answered by AI

How many people can join this trial at most?

"This clinical trial is no longer admitting patients. The study was originally posted on 1/15/2016 and updated for the last time on 7/8/2021. Right now, there are 43 other clinical trials related to barrett esophagus that are recruiting and 180 studies involving Aspirin that are also actively looking for participants."

Answered by AI

Is this study only testing on patients who are over 55 years old?

"From the eligibility requirements listed, it appears that adults aged 18 to 75 are able to take part in this clinical trial. However, there are separate ongoing studies for patients who fall outside of this age range - 18 trials for those under 18 years old and 210 studies involving seniors above the age of 65."

Answered by AI

For what ailments is Aspirin generally prescribed?

"Aspirin is most commonly used to treat percutaneous coronary intervention (pci) and can also be given for dental procedures, neck pain, and general inflammation."

Answered by AI

Are there any available vacancies for patients who want to participate in this research?

"The study in question is not recruiting patients at this time, according to the information available on clinicaltrials.gov. This trial was first posted on 1/15/2016 and was last edited on 7/8/2021. There are a total of 223 other trials that are actively recruiting patients right now."

Answered by AI

Where are patients able to participate in this clinical trial?

"The 11 sites for this clinical trial include Kansas City Veterans Affairs Medical Center in Missouri, Saint Michael's Hospital in Toronto, and University of Pennsylvania/Abramson Cancer Center in Philadelphia."

Answered by AI

Recent research and studies

Digestive Diseases and SciencesJournal

Chemoprevention of Barrett’s Esophagus and Esophageal Adenocarcinoma

Bresalier, Robert S.. 2018. “Chemoprevention of Barrett’s Esophagus and Esophageal Adenocarcinoma”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-018-5149-6.

clinicaltrials.govStudy

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

2016. "Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02521285.

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