A phase III double-blind, placebo-controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours

Can regular aspirin use after standard therapy prevent disease recurrence and prolong survival in participants with common, non-metastatic, solid tumours?

What is this study about?

Cancer is a global problem and the third most common cause of death worldwide, with an estimated 14.1 million cases and 8.1 million deaths in 2012. Add-Aspirin includes participants with breast, colorectal, gastro-oesophageal and prostate tumours which together accounted for approximately one third of all cancer cases and cancer deaths in 2012. 

The Add-Aspirin trial will investigate whether regularly taking aspirin after curative treatment for early stage common solid tumours can prevent tumours returning and prolong survival. As an inexpensive drug with a potential therapeutic role in several common cancers, aspirin could have a huge impact on the global cancer burden, particularly given the increasing cancer incidence in lower resource countries.

There is a considerable body of preclinical data, epidemiological studies and meta-analyses of randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy (given after the main treatment to reduce the chance of the cancer coming back).

Participants entering the Add-Aspirin trial will have already had treatment for breast, colorectal, gastro-oesophageal or prostate cancer with the intention of curing their disease. An important goal for these participants is avoiding recurrent disease, subsequent treatment and mortality. There is a need to identify adjuvant treatments that are effective, relatively low-cost, and feasible to administer in both resource-poor and rich countries.

Research into cancer treatments increasingly focuses on developing new, and usually expensive, agents and regimens, placing a growing strain on health services globally. As a low-cost drug with the potential to improve cancer outcomes, in addition to other possible health benefits, aspirin warrants further investigation as an anti-cancer agent.

Type of study

Randomised trial

Contact details

Who is funding the study?

The trial is being jointly funded by Cancer Research UK, the National Institute for Health Research Health Technology Assessment Programme and the Medical Research Council. In India, the Sir Dorabji Tata Trust provides funding.

When is it taking place?

The trial opened in 2015 and is currently recruiting participants with stomach or oesophagus cancers until approximately 2025. Participants will self-administer tablets daily for up to 5 years and will be actively followed up for up to 10 years.

Where is it taking place?

Hospital sites across the UK and some sites in India and the Republic of Ireland.

Who is included?

Participants who have undergone potentially curative treatment for breast, colorectal, gastro-oesophageal or prostate cancer.