Active not recruitingPHASE2INTERVENTIONAL

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

This study aims to discover if taking a daily aspirin can help prevent Barrett's oesophagus from returning. Patients with Barrett's oesophagus who have successfully had the condition removed using a treatment called radiofrequency ablation are being recruited. Some will take aspirin, and others will take a dummy pill (placebo), for 12 months. Researchers will then check if aspirin is safe to use in this way and if it helps reduce certain markers in tissue samples that are linked to the condition coming back. This could help doctors find new ways to keep Barrett's oesophagus from returning after treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

Start

15 Jan 2016

Estimated completion

30 Mar 2027

Barrett Esophagus Esophageal Adenocarcinoma

Results

Results from this study

Posted May 2023

Results have been published for this study.

Primary outcome

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

Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.) The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Full results on the registry

What is this study about?

Imagine your food pipe (oesophagus) lining has changed, a condition called Barrett's oesophagus. This change sometimes happens in people with long-term acid reflux. While not cancer, it can increase the risk of developing a type of oesophageal cancer.

Doctors can now treat Barrett's oesophagus really well, often by using a special procedure called radiofrequency ablation (RFA). This treatment uses heat to remove the changed cells, making the lining go back to normal. But sometimes, even after successful treatment, Barrett's oesophagus can return. This study wants to see if taking a daily aspirin tablet could prevent that from happening.

The main aim is to find out if aspirin is safe for people who have had Barrett's oesophagus treated and if it can stop certain changes in the body that are linked to the condition coming back. Researchers will also look at how aspirin affects other natural chemical processes in the body. If aspirin can help, it might offer a simple way to keep people healthy after their treatment.

Key takeaways

The study tests if aspirin can prevent Barrett's oesophagus from returning.
Participants have already had their Barrett's oesophagus successfully treated by RFA.
Some patients will take aspirin, others a dummy pill (placebo), for 12 months.
The study measures the safety of aspirin and its effects on certain body markers.
Results could help find new ways to keep Barrett's oesophagus from coming back.
Follow-up appointments continue for 18 months after stopping the medication.

Who may be eligible?

To join this study, you must be an adult between 18 and 75 years old. You must have been diagnosed with Barrett's oesophagus at some point, and importantly, your Barrett's oesophagus must have been completely removed by radiofrequency ablation (RFA). This means your doctors have checked with endoscopies and biopsies at least twice, at least three months apart, and found no more signs of the condition, with the last check being within the last three years.

You also need to be willing to provide small tissue samples for the research. For your safety, we need to make sure your blood counts (like haemoglobin and white blood cells) are within a healthy range. It’s also important that you haven't been regularly taking aspirin or other similar pain medications (NSAIDs) in the month leading up to the study.

If you are able to have children or are a man whose partner could become pregnant, you'll need to agree to use effective contraception throughout your time in the study. This is because the effects of the study medication on an unborn baby aren't fully known.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with Barrett's oesophagus that has been completely removed by RFA within the last 3 years?
Are you able to provide tissue samples for research?
Have you avoided regularly taking aspirin or similar pain relievers (NSAIDs) for at least one month?
Are you willing to use contraception if you or your partner could become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: one group will take a 325 mg aspirin tablet every day, and the other group will take a dummy pill (placebo) every day. Both groups will take their assigned pill for 12 months. Neither you nor your doctor will know which pill you are taking.

Throughout the study, you'll have regular follow-up appointments. After you finish taking the study medicine, you'll continue to have check-ups at 1, 3, 6, 9, 12, and 18 months. During these visits, doctors will monitor your health, check for any side effects, and collect samples (like tissue samples) to help understand how the medication is working. The total duration of your active participation, including the follow-up, will be around 18 months after finishing the medication.

Potential risks and benefits

Participating in this study might offer a potential benefit if aspirin proves to prevent Barrett's oesophagus from returning, though this is not guaranteed. We hope to learn more about how aspirin affects the condition, which could help future patients. However, like all medications, aspirin carries risks, such as stomach upset, bleeding, or allergic reactions. All potential risks will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

UCLA / Jonsson Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
UCHealth University of Colorado Hospital
Verified postcode
Aurora, United States
Northwestern University
Verified postcode
Chicago, United States
Mayo Clinic in Rochester
Verified postcode
Rochester, United States
Kansas City Veterans Affairs Medical Center
Verified postcode
Kansas City, United States
UNC Lineberger Comprehensive Cancer Center
Verified postcode
Chapel Hill, United States
University of Pennsylvania/Abramson Cancer Center
Verified postcode
Philadelphia, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Verified postcode
Houston, United States
M D Anderson Cancer Center
Verified postcode
Houston, United States
Saint Michael's Hospital
Verified postcode
Toronto, Canada

Common questions

What is Barrett's oesophagus?

It's a change in the lining of your food pipe, often due to long-term acid reflux, which can increase the risk of oesophageal cancer.

What is radiofrequency ablation (RFA)?

RFA is a treatment that uses heat to remove the abnormal cells in Barrett's oesophagus, helping the lining return to normal.

Why is aspirin being studied?

Researchers want to see if daily aspirin can help stop Barrett's oesophagus from coming back after it's been successfully treated.

What is a placebo?

A placebo is a dummy pill that looks like the study medication but contains no active drug, used to compare effects accurately.

How long will I take the study tablet?

You will take either aspirin or a placebo once a day for 12 months.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.