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 regular aspirin use after curative treatment for early stage common solid tumours can prevent tumour recurrence 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.
Participants entering the Add-Aspirin trial will have undergone potentially curative treatment for breast, colorectal, gastro-oesophageal or prostate cancer. Avoiding recurrent disease, subsequent treatment and mortality in these participants is an important goal and 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 pharmaceutical 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
Who is funding the study?
The trial is being jointly funded by Cancer Research UK www.cancerresearchuk.org, the National Institute for Health Research Health Technology Assessment Programme www.nihr.ac.uk and the MRC CTU. In India, the Sir Dorabji Tata Trust provides funding.
When is it taking place?
The trial opened to recruitment in October 2015. Participants will self-administer tablets daily for at least 5 years and will be actively followed up for 5 years.
Where is it taking place?
The trial is recruiting in hospital sites across the UK and is also open in 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.