Aspirin for Barrett's Esophagus

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: NSAIDs, Anticoagulants, Corticosteroids, others

Disqualifiers: Renal insufficiency, Recent cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

21 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like NSAIDs (including aspirin), COX-2 inhibitors, and some other specific drugs at least one month before starting the trial. You may need to switch to alternative medications, and this should be discussed with your primary care provider.

What data supports the effectiveness of the drug aspirin for Barrett's Esophagus?

Some studies suggest that aspirin, especially when combined with proton pump inhibitors, may help reduce the risk of cancer progression in patients with Barrett's Esophagus. However, other research shows no significant difference in cancer risk between those taking aspirin and those who are not. ^{1 2 3 4 5}

Is aspirin safe for humans?

Aspirin is generally considered safe for humans, but it can cause side effects like stomach upset, bleeding, and allergic reactions. It's important to talk to a doctor before starting aspirin, especially for long-term use. ^{1 2 3 5 6}

How does aspirin differ from other drugs for Barrett's esophagus?

Aspirin is unique in its potential to reduce the risk of esophageal adenocarcinoma in Barrett's esophagus when combined with proton pump inhibitors, which may decrease all-cause mortality by about 33%. However, its effectiveness as a standalone treatment for preventing cancer progression in Barrett's esophagus is still under investigation, and it may not significantly differ from not using aspirin. ^{1 3 4 5 7}

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.

Research Team

Robert S Bresalier

Principal Investigator

M.D. Anderson Cancer Center

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.

Exclusion Criteria

Receipt of other investigational agents

Pregnant or breastfeeding women

I have been recently diagnosed or treated for cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aspirin or placebo orally once daily for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Visits at 1, 3, 6, 9, 12, and 18 months

Treatment Details

Interventions

• Aspirin

Trial Overview 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.

Participant Groups

Group I: Arm A (aspirin) Experimental Treatment 3 Interventions

Patients receive aspirin PO QD for 12 months.

Group II: Arm B (placebo) Placebo Group 3 Interventions

Patients receive placebo PO QD for 12 months.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient preferences for the chemoprevention of esophageal adenocarcinoma in Barrett's esophagus. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Secondary chemoprevention of Barrett's esophagus with celecoxib: results of a randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Current Status of Chemoprevention in Barrett's Esophagus. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Aspirin is not chemoprotective for Barrett's adenocarcinoma of the oesophagus in multicentre cohort. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Aspirin: the miracle drug? [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Medical treatment of Barrett's esophagus]. [2013]