Aspirin for Barrett's Esophagus

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether aspirin can prevent Barrett's esophagus from returning after successful treatment. Barrett's esophagus involves changes in the esophageal lining, which can sometimes lead to cancer. Participants will take either aspirin or a placebo (a pill with no active ingredient) for 12 months. This trial suits individuals who have had Barrett's esophagus treated with radiofrequency ablation and have been confirmed free of it in follow-up exams. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that aspirin is likely to be safe for humans?

Research shows that most people can take aspirin without problems. Some studies suggest that regular aspirin use may lower the risk of developing Barrett's esophagus, especially in women. This indicates that aspirin could be safe and beneficial for those at risk of this condition.

However, aspirin can cause side effects, such as stomach upset, heartburn, or more serious stomach issues for some individuals. Its widespread use and FDA approval for other conditions provide some reassurance about its safety. Nonetheless, considering possible side effects and consulting a doctor before starting any new treatment is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Barrett's esophagus?

Researchers are excited about using aspirin for Barrett's Esophagus because it offers a simple and potentially effective way to manage the condition. Unlike the standard treatments, which often involve proton pump inhibitors to reduce acid or surgical interventions, aspirin might help by reducing inflammation that's thought to play a role in the progression of Barrett's Esophagus. This anti-inflammatory action could slow or prevent the condition from advancing to more serious stages, like esophageal cancer. Moreover, aspirin is already widely available and affordable, which could make it an accessible option for many patients if proven effective.

What evidence suggests that aspirin might be an effective treatment for Barrett's esophagus?

Research shows that aspirin might help prevent Barrett's esophagus from returning after treatment. Studies have found that people who regularly take aspirin have a lower chance of recurrence. Specifically, higher doses of aspirin have been linked to reducing this risk. In this trial, participants in Arm A will receive aspirin to evaluate its effectiveness in preventing the return of Barrett's esophagus. Other research has shown that using aspirin with acid-reducing medicine can safely improve outcomes for those with Barrett's esophagus, suggesting that aspirin alone might also be effective in preventing its return. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert S Bresalier

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3971896/

Aspirin Chemoprevention in Barrett Esophagus: Is the Risk ... Some data from retrospective case-control studies have suggested that individuals who take aspirin may develop less Barrett esophagus. In addition, data from ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5746603/

Aspirin Use is Associated With Lower Risk of Barrett's ... Regular aspirin use was associated with a reduction in the risk of Barrett's esophagus in women. The reduction in risk appeared related to higher dose and ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(18)31388-6/fulltext

Esomeprazole and aspirin in Barrett's oesophagus (AspECT) High-dose PPI and aspirin chemoprevention therapy, especially in combination, significantly and safely improved outcomes in patients with ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT222777

Chemoprevention of esophageal cancer with ... We have shown that PPI high dose and aspirin chemoprevention therapy, especially in combination significantly reduces rates of death, EA or HGD occurrence and ...

5. ecancer.org ecancer.org/en/news/14131-asco-2018-taking-acid-reducing-medicine-with-aspirin-offers-moderate-benefits-in-patients-with-barretts-oesophagus

ASCO 2018: Taking acid-reducing medicine with aspirin ... ASCO 2018: Taking acid-reducing medicine with aspirin offers moderate benefits in patients with Barrett's oesophagus. 4 Jun 2018. ASCO 2018 ...

6. gastrojournal.org gastrojournal.org/article/S0016-5085(19)32511-9/fulltext

Will a Proton Pump Inhibitor and an Aspirin Keep the ... PPIs likely help most patients with Barrett's esophagus. Discuss starting aspirin. Reduce risk factors, especially smoking and obesity.