Aspirin for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether taking low-dose aspirin daily can help prevent colorectal cancer. Participants will be randomly assigned to take either aspirin or a placebo (a pill with no active ingredient) for 12 weeks. Those who have had at least one adenoma (a type of polyp that can turn into cancer) removed after a recent colonoscopy might be a good fit. Participants should not currently take aspirin and must be able to swallow pills.
As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that you stop taking any aspirin or non-aspirin NSAIDs (like ibuprofen) before joining. If you're on anticoagulants (blood thinners) or antiplatelet agents, you cannot participate. It's best to discuss your current medications with the study team to see if you need to make any changes.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that low-dose aspirin is usually safe for most people. Even when taken daily in higher amounts, studies have found it to be generally well tolerated. For example, one study found that aspirin was safe for patients who had completed standard cancer treatments. Although this study did not focus on cancer prevention, it still contributes to understanding aspirin's safety.
Aspirin often reduces the risk of heart problems, but it can sometimes cause side effects like stomach upset or bleeding. However, these risks are smaller with low doses. Since the FDA has already approved aspirin for other uses, its safety is well understood and managed.
In summary, while aspirin does have some risks, research suggests that low doses are generally safe for most people.12345Why do researchers think this study treatment might be promising for colorectal cancer?
Unlike the standard treatments for colorectal cancer, which often include chemotherapy, radiation, and surgery, low-dose aspirin offers a potentially simpler approach. Researchers are excited about aspirin because it may reduce inflammation and inhibit platelet aggregation, which are thought to play a role in cancer progression. This treatment is also appealing due to its long history of safety at low doses and its potential to be an easy, cost-effective addition to current treatment regimens.
What evidence suggests that low dose aspirin might be an effective treatment for colorectal cancer?
Research has shown that taking low-dose aspirin might help prevent colorectal cancer. In one study, participants taking aspirin were 55% less likely to experience cancer recurrence compared to those taking a placebo, which contains no active medicine. This trial will compare the effects of low-dose aspirin (81 mg) with a placebo. Other research indicates that even a low dose of 325 mg per day can lower the risk of developing colorectal cancer. Aspirin has also been shown to help prevent certain types of polyps, which can turn into cancer, from returning in healthy individuals. For those with Lynch syndrome, a condition that increases cancer risk, taking aspirin significantly reduced the chances of developing colorectal cancer. These findings suggest that aspirin could be a promising option for preventing colorectal cancer.12467
Who Is on the Research Team?
Andrew Chan, MD, Ph.D
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults who've had at least one adenoma removed via colonoscopy in the last 9 months, are aged 18-55 or over 65, and haven't taken aspirin recently. Excluded are those with certain diseases (like inflammatory bowel disease), prior gastrointestinal cancers, recent use of NSAIDs, or conditions affecting study compliance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily low-dose aspirin or placebo for the duration of the study
Follow-up
Participants may be contacted periodically for up to 10 years to follow-up on additional information
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
Trial Overview
The ASPIRED-XT study is testing low-dose Aspirin as a preventive treatment for colorectal cancer compared to a placebo. Participants will be randomly assigned to receive either Aspirin or an inactive substance to evaluate its effectiveness in reducing cancer risk.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.
Participants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks.
Aspirin is already approved in European Union, United States, Canada, China for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
Aspirin May Reduce Risk of Colorectal Cancer Recurrence ...
For Group A and Group B combined, patients who took aspirin were 55% less likely to have their cancer recur than those who took a placebo.
Aspirin as secondary prevention for colorectal cancer liver ...
This phase 3 trial showed that in patients with colorectal cancer liver metastasis, daily aspirin 160 mg after complete tumor removal did not improve disease- ...
Aspirin for the prevention of colorectal cancer - PubMed Central
Taking clinical trial and observational data together, there is clear evidence that aspirin in doses as low as 325 mg per day reduces CRC risk.
Aspirin after completion of standard adjuvant therapy for ...
Randomised trials have shown that aspirin is effective in reducing recurrent adenomatous polyps in healthy individuals and in reducing colorectal cancer in ...
Cancer prevention with aspirin in hereditary colorectal ...
Two standard aspirins per day for 2 years results in a significant reduction in colorectal cancer incidence in Lynch syndrome carriers, which ...
Colorectal Cancer || Cardiovascular Disease || Bleeding
In this study researchers want to learn more about the effect of low-dose Aspirin on cancer that develops in the colon (the longest part of the large intestine) ...
Does Regular Use of Aspirin Improve Colorectal Cancer ...
Research results have been mixed about whether regularly taking aspirin or another NSAID helps improve the survival of people who have been diagnosed with CRC.
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