Trial Testing Aspirin to Prevent Cancer Recurrence

(Mostafa Zeyad, Wikimedia Commons)

22 October 2015. A new late-stage clinical trial is underway in the U.K. testing the ability of a daily aspirin to prevent the recurrence of solid tumor cancers. The trial is financed by the advocacy group Cancer Research UK and National Institute for Health Research, a medical research funding agency.

The study, led by oncologist Ruth Langley at University College London, seeks to determine if ordinary aspirin, an inexpensive over-the-counter pain medication, taken every day for five years, can delay or stop the recurrence of solid tumor cancers among people who detected their cancer in early stages and already received treatment. Reviews of studies testing aspirin on specific types of cancer and some clinical trials point to a reduced incidence of cancer and lower cancer mortality. But so far, no randomized clinical trial provides a clear picture of its effects across multiple types of cancer.

“This trial aims to answer this question once and for all,” says Langley in a joint statement from the study’s funders. “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.”

The clinical trial, named Add-Aspirin, aims to recruit some 11,000 participants at 100 sites in the U.K. People taking part will already be diagnosed with one of four types of solid tumor cancer: colorectal, breast, prostate, or gastroesophageal. Participants will also have received their primary treatments, including surgery, chemotherapy, or radiation.

Each type of cancer will be studied separately in parallel trials, with each trial having 2,000 to 3,000 participants and a similar structure. Individuals will be randomly and blindly assigned to receive aspirin doses of 300 milligrams, 100 milligrams, or a matching placebo, taken daily for five years. The study team will look primarily for recurrence of cancer in participants and survival time. Secondary measures include overall survival, adherence to the aspirin regimen, and side effects such as gastrointestinal complications or cardiovascular problems.

The side effects underscore a point made by the researchers that aspirin is not without its risks. Concerns over toxicity with some individuals and internal bleeding limit the use of aspirin as a primary therapy for cancer. As a supporting therapy, however, the risks can be assessed against their benefits in reducing recurrence of cancer and extending survival times.

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