A trial looking at aspirin and esomeprazole to help prevent cancer of the oesophagus (ASPECT)

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Phase 3

This trial was done to find out if aspirin and esomeprazole can help prevent cancer of the food pipe (oesophagus) in people with Barrett's oesophagus. It was supported by Cancer Research UK.

More about this trial

Barrett’s oesophagus is a condition where the cells lining the oesophagus change. It is caused by acid from the stomach coming back up into the oesophagus (acid reflux). People with Barrett’s oesophagus have an increased risk of developing oesophageal cancer. Researchers are keen to find a way to reduce this risk.

Esomeprazole is a type of drug called a proton pump inhibitor or PPI. It reduces the amount of acid produced by the stomach. Doctors hoped that it would help stop Barrett’s oesophagus developing into cancer.

Other clinical trials had already shown that aspirin may help prevent oesophageal cancer. But the research team were not sure how useful it is for people with Barrett’s oesophagus. Aspirin can cause stomach ulcers, but doctors hoped that having esomeprazole with aspirin would stop that happening.

Some people in this trial had high dose esomeprazole and some had low dose esomeprazole. Some also took aspirin.

The aim of this trial was to see if esomeprazole with or without aspirin could help stop Barrett’s oesophagus developing into oesophageal cancer.

Summary of results

The results showed that the combination of esomeprazole and aspirin could help prevent oesophageal cancer in people with Barrett’s oesophagus.

The research team recruited people between 2005 and 2009, and reported the results in 2018.

Results

The research team recruited 2,557 people with Barrett’s oesophagus. About 8 out of 10 were men, and 2 out of 10 were women.

The people taking part were put into 1 of 4 groups at random:

705 people were in group 1 and had low dose esomeprazole and no aspirin
704 people were in group 2 and had high dose esomeprazole and no aspirin
571 people were in group 3 and had low dose esomeprazole and aspirin
577 people were in group 4 and had high dose esomeprazole and aspirin

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The research team looked at how many people in each group developed precancerous cells (high grade dysplasia) or oesophageal cancer or died. They found that out of every 100 people it was:

14 people who had low dose esomeprazole and no aspirin
12 people who had high dose esomeprazole and no aspirin
13 people who had low dose esomeprazole and aspirin
9 people who had high dose esomeprazole and aspirin

The research team have estimated how much each treatment could help reduce the risk of precancerous cells, oesophageal cancer or dying prematurely.

They compared those who had low dose esomeprazole (groups 1 and 3) with those who had high dose esomeprazole (groups 2 and 4). They estimate that if 34 people take high dose esomeprazole instead of low dose, it will help stop 1 person developing precancerous cells or oesophageal cancer or dying.

They also compared those who didn’t have aspirin (groups 1 and 2) with those who did have aspirin (groups 3 and 4). They estimate that if 43 people take aspirin rather than no aspirin, it will help stop 1 person developing precancerous cells or oesophageal cancer or dying.

Side effects

About 4 out of 10 people who took part in this trial had side effects, but many were mild or didn’t last long.

A small number of people had more severe side effects such as heart problems or unusual bleeding. The research team found that these were caused by aspirin in 15 people, and by esomeprazole in 13 people. This is about 1 out of every 100 people (1%) who took part.

Conclusion

The research team concluded that the combination of high dose esomeprazole and aspirin could help prevent precancerous cells, oesophageal cancer or people dying prematurely. And that it didn’t cause too many side effects.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item

) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.