A trial looking at whether aspirin can stop cancer coming back after treatment (Add Aspirin)

Cancer type:

Bowel (colorectal) cancer
Breast cancer
Colon cancer
Oesophageal cancer
Prostate cancer
Rectal cancer
Stomach cancer

Status:

Open

Phase:

Phase 3

This trial is looking at using aspirin to see if it can help stop cancer coming back after treatment. This trial is open to people who have had an early stage Open a glossary item cancer of one of the following

This trial is supported by Cancer Research UK.

More about this trial

Doctors can treat these cancers with

After treatment you see your doctor regularly to make sure the cancer isn’t coming back.

If you have breast cancer or prostate cancer you may also take hormone therapy for a number of years. If you have stomach cancer, cancer of the food pipe or bowel cancer there is usually no further treatment to stop the cancer coming back.

Aspirin is a common painkiller drug that doctors use to prevent heart attacks and stroke in some people. The results of research into using aspirin to prevent heart attacks or strokes has suggested that people who take aspirin regularly are less likely to develop cancer and if they do it is less likely to spread.

In this trial researchers will look at using aspirin to prevent cancer coming back after treatment. Because it isn’t known how much aspirin is needed they will compare daily use of

  • Two different doses of aspirin
  • Dummy drug (placebo Open a glossary item)

The aims of this trial are to

  • See if aspirin can stop cancer coming back after treatment
  • Find which dose works best
  • Learn more about the side effects and health benefits of aspirin in people who have had cancer

Who can enter

You may be able to join this trial if all of the following apply

  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • Your kidneys are working well enough (the trial doctor will test you for this)
  • You are at least 16 years old

And you are in one of the following situations.

Your breast cancer

  • Has grown into the surrounding healthy tissue (invasive breast cancer Open a glossary item)
  • Has been removed by surgery
  • Has spread to lymph nodes Open a glossary item or, if it hadn’t, your cancer had features that suggest it is at high risk of coming back (your doctor can advise you about this)
  • Has been tested for hormone receptors

Your bowel cancer

  • Is a type called adenocarcinoma Open a glossary item
  • Has grown into the muscle or the outer wall of the bowel (stage T2 or stage T3)
  • Has been removed by surgery with the aim to cure it

Your cancer of the oesophagus or cancer of the stomach

  • Is a type called adenocarcinoma or squamous cell Open a glossary item
  • Has been removed by surgery or you have had a combination of chemotherapy Open a glossary item and radiotherapy with the aim to cure the cancer

Your prostate cancer

  • Is a type called adenocarcinoma
  • Has not spread to any lymph nodes
  • Is an intermediate or high risk of coming back (your doctor can advise you about this)
  • Has been removed by surgery, or you have had radiotherapy, with the aim to cure. If you have had your prostate gland removed but are having radiotherapy because of a rise in your PSA Open a glossary item you may still be able to take part, your doctor can advise you

You cannot join this trial if any of these apply. You

  • Have cancer that has spread to another part of the body
  • Have, or had, taken aspirin on a regular basis
  • Are taking a non steroidal anti inflammatory drug (NSAID) Open a glossary item
  • Are allergic to aspirin or similar drugs
  • Are taking regular steroid tablets or have previously taken steroid tablets for a long period of time (your doctor can advise about this)
  • Are taking medication to thin your blood such as warfarin
  • Have, or recently had, a peptic ulcer Open a glossary item
  • Have, or recently had, any bleeding from your food pipe (oesophagus) or stomach unless the cause of the bleeding has been removed by surgery
  • Have another cancer apart from some early cancers Open a glossary item that have been successfully treated or any other cancer that has been successfully treated and there has been no sign of it for at least 15 years
  • Have very low levels of a body protein called G6PD (your doctor can advise you about this)
  • Are sensitive or allergic to a sugar found in milk called lactose (lactose intolerant)
  • Have any other medical or mental health problem that your doctor thinks could affect you taking part in this trial
  • Are pregnant or breastfeeding

For men with prostate cancer you also cannot join the trial if you

Trial design

This is an international phase 3 trial. The researchers need around 9,200 people from the UK to join.

At the start everyone will take aspirin once a day for 8 weeks. This is to make sure that you have no problems taking aspirin. This is called a run-in period.

After this, it is a randomised trial. You are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  And neither of you will know which group you are in. This is called a double blind trial.

  • People in one group will have a low dose of aspirin
  • People in another group will have a higher  dose of aspirin
  • People in the last group will have a dummy drug (placebo Open a glossary item)

Both aspirin and the dummy drug are tablets you take once a day. You take them for 5 years.

If you agree to take part in this trial, the researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item and for some extra blood samples. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

The trial team will ask you to fill out a questionnaire before you start treatment, at 1 year and 5 years. The questionnaire will assess your memory and thought processes. This is called a cognitive assessment.

Hospital visits

You see the doctor to have a physical examination and blood tests before taking part in the trial. If you have breast cancer you will also have a mammogram.

You may have extra visits for some tests or scans. But where possible any tests or scans needed for the trial will be done at your routine follow up appointment with your doctor.

After 5 years at the end of treatment you see the doctor for a physical examination and blood tests.

Side effects

Aspirin is a drug that is commonly used and most people don’t have side effects. The most common side effects of aspirin include

  • Indigestion
  • Irritation of the stomach
  • Bruising or bleeding more easily

The trial doctor will talk to you about the possible side effects of aspirin before you agree to take part in the trial.

Location

Abergavenny
Ashford
Ashington
Aylesbury
Ayr
Bangor
Barnstaple
Barrow in Furness
Basildon
Basingstoke
Bedford
Birmingham
Blackpool
Boston
Bournemouth
Bradford
Brighton
Brighton
Bristol
Burton on Trent
Bury
Bury St Edmunds
Cambridge
Canterbury
Cardiff
Carlisle
Carmarthen
Chelmsford
Cheltenham
Chertsey
Chester
Chichester
Colchester
Coventry
Crewe
Darlington
Dartford
Denbighshire
Derby
Dudley
Dunfermline
Eastbourne
Edinburgh
Exeter
Frimley
Gateshead
Gillingham
Glasgow
Greenock
Guildford
Halifax
Harlow
Harrow
Hartlepool
Haverfordwest
Hereford
High Wycombe
Huddersfield
Huntingdon
Inverness
Ipswich
Keighley
Kendal
Kettering
Kidderminster
Kilmarnock
Kings Lynn
Kingston upon Thames
Kirkcaldy
Lancaster
Larbert
Leeds
Leicester
Lincoln
Liverpool
Llandough
London
Luton
Macclesfield
Maidstone
Manchester
Margate
Merthyr Tydfil
Middlesbrough
Milton Keynes
Newcastle upon Tyne
Newport
Newport (IOW)
North Shields
Northampton
Northwood
Norwich
Nottingham
Nuneaton
Oldham
Oxford
Paisley
Peterborough
Plymouth
Portsmouth
Reading
Redditch
Redhill
Romford
Rotherham
Salisbury
Scarborough
Sheffield
Shrewsbury
South Shields
Southampton
Southend on Sea
St Leonards-on-sea
Stevenage
Stockton-on-Tees
Stoke-on-Trent
Sunderland
Sutton
Sutton in Ashfield
Swansea
Swindon
Taunton
Torquay
Truro
Wakefield
Walsall
Weston Super Mare
Whitehaven
Wigan
Winchester
Wirral
Worcester
Worthing
Wrexham
Yeovil
Ynysmaerdy

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Ruth Langley

Supported by

Cancer Research UK
Bayer Pharma AG
Experimental Cancer Medicine Centre (ECMC)
MRC Clinical Trials Unit at UCL
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
TATA Memorial Centre

Other information

This is Cancer Research UK trial number CRUK/12/033.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10080

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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