"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at whether aspirin can stop cancer coming back after treatment (Add Aspirin)
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
- Breast cancer
- Cancer of the food pipe (oesophagus)
- Stomach cancer
- Prostate cancer
- Bowel (colorectal) cancer
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 (
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)
- Has been removed by surgery
- Has spread to
lymph nodesor, 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
- 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
- Has been removed by surgery or you have had a combination of
chemotherapyand 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
PSAyou 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)
- 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
- 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 cancersthat 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
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 (
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
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.
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.
Aspirin is a drug that is commonly used and most people don’t have side effects. The most common side effects of aspirin include
- 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.
How to join a clinical trial
Professor Ruth Langley
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
This is Cancer Research UK trial number CRUK/12/033.