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A trial looking at aspirin and esomeprazole as a way of preventing cancer of the food pipe (oesophagus) (ASPECT & WASP trials)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

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

This information is about the ASPECT trial which is only recruiting men. A similar trial for women called the WASP trial has now finished recruiting.

In ‘ Barrett’s oesophagus’ the cells lining the food pipe (gullet or oesophagus) change. This 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. This means that 1 person out of 100 with Barrett's oesophagus will go on to develop cancer.

Esomeprazole is a drug called a proton pump inhibitor (PPI). It reduces the amount of acid produced by the stomach. Doctors think that esomeprazole may help to prevent Barrett’s oesophagus developing into cancer of the oesophagus. But they are not sure yet how well it will work.

Clinical trials in the past have shown that aspirin may help to prevent oesophageal cancer. But they are not sure how useful it is for people with Barrett’s oesophagus. Aspirin can cause stomach ulcers, but doctors hope that giving esomeprazole with aspirin will prevent that happening.

The aim of this trial is to see if high or low dose esomeprazole alone, or esomeprazole and aspirin together can help stop Barrett’s oesophagus developing into oesophageal cancer.

Recruitment

Start 01/03/2005
End 28/02/2009

Phase

Phase 3

Who can enter

You can enter this trial if you are at least 18 years of age and either

  • Have an area of Barrett’s oesophagus all the way round your oesophagus (circumferential) that is at least 1cm long, or
  • Have an area of Barrett's oesophagus that does not ago all the way round your oesophagus (non circumferential) that is at least 2cm long

You cannot enter this trial if you

Trial design

This is a randomised trial. It will recruit about 2,000 men. There are 4 groups. The people taking part will be put into a treatment group by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • If you are in group 1 you will take a lower dose of esomeprazole and no aspirin
  • If you are in group 2 you will take a high dose of esomeprazole and no aspirin
  • If you are in group 3 you will take aspirin and a lower dose of esomeprazole
  • If you are in group 4 you will take aspirin and a higher dose of esomeprazole

If you are already taking aspirin or are unable to take aspirin you will be randomised into either group 1 or 2 only.

Both aspirin and esomeprazole are tablets that you take at home. You take asprin once a day. If you are in groups 2 or 4, you take esomeprazole twice a day. If you are in groups 1 or 3, you take it just once a day. You will take tablets every day for up to 8 years.

Hospital visits

You will have some tests before you take part in this trial. These include blood tests and a physical examination. The doctors will use a small camera to look down your throat at the inside of your oesophagus (an endoscopy).

You will see the doctors at the hospital and have an endoscopy every 2 years for 8 years. You will need to go to the hospital pharmacy every 6 months to take back any tablets you have left over, and collect a new supply.

Side effects

The side effects of aspirin include

  • Stomach irritation
  • Abdominal pain
  • Dizziness
  • Raised blood pressure
  • Feeling sick
  • Diarrhoea

The side effects of esomeprazole include

  • Abdominal pain
  • Headache
  • Diarrhoea
  • Feeling sick

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Janusz Jankowski

This is Cancer Research UK trial number CRUK/05/006.

Supported by

Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)
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Updated: 28 September 2009