A trial looking at whether aspirin can stop cancer coming back after treatment (Add Aspirin)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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 
cancer of one of the following
- Breast cancer (closed)
- Cancer of the food pipe (oesophagus)
- Stomach cancer
- Prostate cancer (closed)
- Bowel (colorectal) cancer (closed)
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 )
Please note
From the 1st April 2023 when you join the trial you will go into one of the following groups either
- A low dose 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
You have cancer of the oesophagus or cancer of the stomach
- That is a type called adenocarcinoma or
squamous cell - Has been removed by surgery or you have had a combination of
chemotherapy and radiotherapy with the aim to cure the cancer
Please note
The trial team have enough people in the following cancer groups. They are now closed to recruitment
- Breast cancer
- Bowel cancer
- Prostate cancer
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
peptic ulcer - 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 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
- Have had surgery to remove your testicles (bilateral orchidectomy)
- Are planned to have hormone therapy for more than 3 years after your main treatment
Trial design
This is an international phase 3 trial. The researchers need around 8,600 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 2 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.
The groups are you take
- a low dose of aspirin
- a dummy drug (
placebo )
Out of every 3 people who join the trial 2 people go into the group that takes a low dose of aspirin and 1 person will go into the group that takes the 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 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.
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.
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
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUK/12/033.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
