Aspirin for Colorectal Cancer

Overseen By Andrew T Chan, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must not be taking: NSAIDs, Anticoagulants

Disqualifiers: Inflammatory bowel disease, Liver disease, Kidney disease, Gastrointestinal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

161 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

Ability to understand and the willingness to sign a written informed consent document

I had a colonoscopy and had at least one adenoma removed in the last 9 months.

Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria

Pregnant or breastfeeding

Receiving any other investigational agents

I have had an adenoma that was not fully removed in a past colonoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive daily low-dose aspirin or placebo for the duration of the study

12 weeks

2 visits (in-person)

Follow-up

Participants may be contacted periodically for up to 10 years to follow-up on additional information

Up to 10 years

1-2 contacts annually (virtual or phone)

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?

Group I: Placebo Experimental Treatment 1 Intervention

Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.

Group II: Low Dose Aspirin Experimental Treatment 1 Intervention

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:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 3052 patients undergoing colonoscopy, aspirin use did not affect the diagnostic accuracy of the faecal immunochemical test (FIT) for detecting colorectal cancer (CRC) or advanced neoplasia (AN).

However, patients taking 300 mg/day or more of aspirin showed a lower prevalence of advanced neoplasia and had significantly reduced sensitivity and specificity in the FIT test, indicating that high doses of aspirin may impair test accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aspirin on the diagnostic accuracy of the faecal immunochemical test for colorectal advanced neoplasia. Bujanda, L., Sarasqueta, C., Vega, P., et al.[2022]

Citations

1. asco.org asco.org/about-asco/press-center/news-releases/new-findings-aspirin-and-risk-colorectal-cancer-recurrence

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.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3511

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- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3354696/

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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S246812532400387X

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 ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)30366-4/fulltext

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 ...

6. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/20751

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) ...

7. cancer.org cancer.org/research/acs-research-highlights/colon-and-rectal-cancer-research-highlights/survivorship-colorectal-cancer-studies/regular-use-of-aspirin-may-help-improve-survival-after-a-diagnos.html

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.