Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours
The Add-Aspirin study is investigating if taking aspirin regularly after completing standard treatment for certain common cancers can prevent the cancer from returning and improve overall survival. The study focuses on breast, bowel (colorectal), stomach/gullet (gastro-oesophageal), and prostate cancers that have not spread (non-metastatic). Participants will be randomly given either a 100mg aspirin, 300mg aspirin, or an inactive dummy pill (placebo) to take daily for at least five years. Researchers will then check if aspirin makes a difference to how long people live and if their cancer comes back. This is important because aspirin is cheap and widely available, and past research suggests it might have anti-cancer effects.
At a glance
What is this study about?
The Add-Aspirin study is a really important research project looking into whether a common, everyday medicine – aspirin – can help people who have already had treatment for certain types of cancer. If you've been treated for breast, bowel (colorectal), stomach/gullet (gastro-oesophageal), or prostate cancer that hasn't spread to other parts of your body, this study wants to find out if taking aspirin regularly afterwards can stop the cancer from coming back and improve how long you live.
Researchers already have some clues that aspirin might be helpful against cancer. Previous studies, originally looking at aspirin for heart health, showed that it might reduce the risk of cancer coming back or even improve survival. Also, some observations from people who took aspirin after their cancer treatment have suggested positive effects for specific cancer types. However, we don't have a clear answer from a large, well-designed study yet.
That's why this trial is so important. It's designed to give us that clear answer. Because aspirin is a low-cost, widely available medicine, if it's proven to be effective, it could make a huge difference to many people affected by cancer, not just in the UK but around the world.
Key takeaways
- The study tests if aspirin can stop cancer returning and improve survival.
- It's for common cancers like breast, bowel, and prostate, after initial treatment.
- Participants take 100mg aspirin, 300mg aspirin, or a dummy pill daily for 5+ years.
- Aspirin is cheap and common; if effective, it could help many people.
- Your health will be carefully monitored throughout the study.
Who may be eligible?
This study is for adults aged 16 and over a certain type of cancer that hasn't spread. You would have already finished your main cancer treatment, such as surgery, and any other standard treatments like chemotherapy or radiotherapy, for breast, bowel (colorectal), stomach/gullet (gastro-oesophageal), or prostate cancer. Crucially, your doctors must confirm that there's no sign of the cancer remaining or having spread after your treatment.
To be considered, you'll need to be in reasonably good health overall, able to manage normal daily activities. Women should not be pregnant or breastfeeding, and should not plan to be during the study. Before officially joining, you'll also be asked to take a low dose of aspirin for about eight weeks. This helps check if your body tolerates aspirin well and if you can stick to taking the medication consistently. This 'run-in' period helps make sure the study is safe and effective for everyone involved.
There are also specific criteria for each cancer type, which your doctor will go through with you. For example, for breast cancer, the study looks at certain features of the cancer, like whether lymph nodes were involved or what type of tumour it was, to make sure you're a good fit for the research.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have I completed standard treatment for breast, bowel, stomach/gullet, or prostate cancer?
- Has my doctor confirmed my cancer has not spread and there's no sign of it left?
- Am I aged 16 or older and generally able to perform daily activities?
- If I am a woman, am I not pregnant or breastfeeding, and not planning to be during the study?
- Am I willing to take aspirin (or a dummy pill) daily for at least 5 years and be monitored regularly?
What does participation involve?
If you decide to take part, you'll first have an eight-week 'run-in' period where you'll take a low dose (100mg) aspirin every day. This helps make sure aspirin is suitable for you. After this, you'll be randomly assigned to one of three groups, like drawing lots: one group will take a 100mg aspirin every day, another will take a 300mg aspirin every day, and the third group will take a dummy pill (placebo).
Neither you nor your study doctor will know which group you are in – this helps keep the study fair. All pills will have a special coating to help protect your stomach, and you'll take them daily for at least five years. Regularly throughout the study, you'll have appointments to check on how you're feeling, if there are any side effects, and to make sure you're taking your medication as prescribed. Researchers will also keep track of whether your cancer comes back and your overall health. The total time you'd be involved in the study would be at least five years, or potentially longer, to carefully monitor the effects over time.
Potential risks and benefits
Locations (82)
- Bon Secours HospitalVerified postcodeCork, Ireland
- Cork University HospitalVerified postcodeCork, Ireland
- Beaumont HospitalVerified postcodeDublin, Ireland
- Mater Misericordiae University HospitalVerified postcodeDublin, Ireland
- Mater Private HospitalVerified postcodeDublin, Ireland
- St Luke's HospitalVerified postcodeDublin, Ireland
- St Vincent's HospitalVerified postcodeDublin, Ireland
- Tallaght University HospitalVerified postcodeDublin, Ireland
- University College Hospital GalwayVerified postcodeGalway, Ireland
- University Hospital LimerickVerified postcodeLimerick, Ireland
- Sligo University HospitalVerified postcodeSligo, Ireland
- University Hospital WaterfordVerified postcodeWaterford, Ireland
Common questions
What kind of cancers is this study for?
It's for people who have been treated for breast, bowel (colorectal), stomach/gullet (gastro-oesophageal), or prostate cancer that has not spread.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the real medicine but contains no active drug. It helps compare the aspirin's effects fairly.
How long would I need to take the study medication?
You would take the study medication daily for at least five years, after an initial 8-week trial period.
Will I know if I'm taking aspirin or the dummy pill?
No, neither you nor your study doctor will know if you're taking aspirin or the dummy pill. This is called 'double-blind' and helps keep the study unbiased.
What if I experience side effects?
The study team will monitor you closely for any side effects. You should report any concerns to them immediately, and they will provide guidance and support.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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