World's largest ever clinical trial: Aspirin v Cancer Recurrence

The world’s largest ever clinical trial looking at whether taking aspirin every day stops some of the most common cancers coming back, launches across the UK today.

“This trial is especially exciting as cancers that recur are often harder to treat so finding a cheap and effective way to prevent this is potentially game-changing for patients.” - Dr Fiona Reddington, Cancer Research UK

The Add-Aspirin phase III trial*, the largest of its kind and funded by Cancer Research UK and the National Institute for Health Research(link is external), aims to find out if taking aspirin every day for five years can stop or delay cancers that have been caught and treated at an early stage from returning. It will also study how the drug might do this.

The study will recruit 11,000 patients who have recently had, or are having, treatment for bowel, breast, oesophagus (food pipe), prostate or stomach cancer. It will be open at more than 100 centres across the UK and will run for up to 12 years.

The study will compare two groups of people taking different doses of aspirin** and a group taking placebo (dummy) tablets.

Aspirin is already proven to help prevent heart attacks and strokes in some people, and research has suggested that it could also prevent some types of cancer.

Professor Ruth Langley, chief investigator from the MRC Clinical Trials Unit at UCL(link is external), said: “There’s been some interesting research suggesting that aspirin could delay or stop early stage cancers coming back, but there’s been no randomised trial to give clear proof. This trial aims to answer this question once and for all. If we find that aspirin does stop these cancers returning, it could change future treatment – providing a cheap and simple way to help stop cancer coming back and helping more people survive.

“But, unless you are on the trial, it’s important not to start taking aspirin until we have the full results as aspirin isn’t suitable for everyone, and it can have serious side effects. Please speak to your oncologist or research nurse if you would like to join the Add-Aspirin trial.”

Mother of two Alex King, 51, was diagnosed with breast cancer in December 2009. She said: “Having cancer was one of the toughest experiences of my life, but thankfully I was one of the lucky ones given the all-clear and I’ve been free of cancer for five years now. Any opportunity to reduce the chance of cancer coming back is incredibly important so patients can rest more easily, and it’s brilliant to see that Cancer Research UK is launching this new trial to see if aspirin can help do this.”

Professor Tom Walley, director of the NIHR Health Technology Assessment (link is external)(HTA) programme, said: “We have funded the Add-Aspirin trial because it offers the exciting possibility of improved outcomes for patients, with a simple well tolerated intervention. The NIHR HTA programme prides itself on funding pragmatic clinical trials like this that can lead to tangible benefits to patients and could help fill important knowledge gaps for the NHS.”

Dr Fiona Reddington, Cancer Research UK’s head of population research, said: “Aspirin’s possible effects on cancer are fascinating and we hope this trial will give us a clear answer on whether or not the drug helps stop some cancers coming back.

“This trial is especially exciting as cancers that recur are often harder to treat so finding a cheap and effective way to prevent this is potentially game-changing for patients.”

For more information about the trial call 0808 800 4040 to speak to Cancer Research UK’s information nurses or visit www.cancerhelp.org.uk(link is external)