Aspirin for Colorectal Cancer Prevention

(ASPIRED Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: NSAIDs, Anticoagulants

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether aspirin can help prevent colorectal cancer. Participants will receive either a low dose, a standard dose, or a placebo (a pill with no active drug) for up to 12 weeks. The trial targets individuals who recently had a colonoscopy, had at least one adenoma (a type of polyp) removed, and have not used aspirin in the last six months. The study aims to determine if aspirin can lower the future risk of developing colorectal cancer. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new preventive strategies for colorectal cancer.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any aspirin or non-aspirin NSAIDs (like ibuprofen) before joining. If you're on blood thinners or antiplatelet drugs, you can't participate. The protocol doesn't specify other medications, so check with the trial team about your specific situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aspirin is generally safe when taken in low doses. Studies have found that doses as low as 325 mg per day can lower the risk of colorectal cancer, indicating good tolerance for this use. One study discovered that patients taking aspirin were 55% less likely to experience a recurrence of colorectal cancer compared to those on a placebo, highlighting aspirin's potential benefits in cancer prevention.

Additionally, aspirin is approved for preventing heart-related diseases, further supporting its safety. In one study, low-dose aspirin significantly reduced major heart-related events, demonstrating its established use in other health areas. Overall, aspirin's safety and potential benefits make it a promising option for reducing the risk of colorectal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using aspirin for colorectal cancer prevention because it offers a potentially simple and widely accessible way to reduce cancer risk. Unlike some current treatments that involve more invasive procedures or expensive medications, aspirin is a common, low-cost drug with anti-inflammatory properties that could help prevent cancerous growths. The trial is examining both low-dose (81 mg) and standard-dose (325 mg) aspirin, providing insights into the most effective dosing for protection. This approach could help make preventive care more accessible and easier for people at risk of colorectal cancer.

What evidence suggests that aspirin might be an effective treatment for colorectal cancer prevention?

Research has shown that aspirin can greatly lower the risk of colorectal cancer. In this trial, participants will receive either a low dose (81 mg), a standard dose (325 mg) of aspirin, or a placebo. Studies have found that taking as little as 325 mg of aspirin daily can reduce the chance of developing this type of cancer. In another study, individuals taking aspirin were 55% less likely to experience a recurrence of their cancer compared to those who took a placebo, which contains no active medicine. Evidence also links even low-dose aspirin to a reduced risk of developing colorectal and other types of cancers. Overall, strong clinical data supports aspirin's potential to prevent colorectal cancer. ^{1 2 6 7 8}

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 aged 18-80 who've had at least one adenoma removed via colonoscopy in the last 9 months, are not currently on aspirin, and can sign consent. Excluded are those on anticoagulants or NSAIDs regularly, with certain genetic syndromes like FAP or Lynch Syndrome, uncontrolled illnesses, pregnant/breastfeeding women, and those unable to swallow pills.

Inclusion Criteria

I haven't taken aspirin in the last 6 months.

I agree to use birth control during the study.

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

Exclusion Criteria

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

I can swallow pills.

I have been diagnosed with inflammatory bowel, liver, or kidney disease, or a bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily low-dose or standard-dose aspirin or placebo for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Placebo for Aspirin

Trial Overview The study is looking into whether taking aspirin can help prevent colorectal cancer in people who have had adenomas removed. Participants will either receive aspirin or a placebo (a pill without any medicine) to compare the effects.

How Is the Trial Designed?

Group I: Low Dose Aspirin Active Control 1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Group II: Standard Dose Aspirin Active Control 1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Group III: Placebo (For Aspirin) Placebo Group 1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 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 Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Aspirin and other NSAIDs show promise in preventing colorectal cancer and potentially other cancers, but more research is needed to fully understand their risk-benefit profiles and to make definitive recommendations.

Aspirin is favored for chemoprevention due to its cardiovascular benefits, but studies are required to determine the optimal dosage, treatment duration, and specific populations that would benefit most while minimizing side effects like peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. Cuzick, J., Otto, F., Baron, JA., et al.[2022]

Aspirin is the most effective agent for reducing colorectal cancer risk, although evidence for its impact on mortality is limited, while COXIBs show similar efficacy for gastrointestinal lesions but carry a higher risk of upper GI complications.

COXIBs may be beneficial for patients with familial adenomatous polyposis, but their use in older adults should be cautious due to increased GI and cardiovascular risks, suggesting that combining them with aspirin and proton-pump inhibitors may be safer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclooxygenase-2 inhibitors in colorectal cancer prevention: counterpoint. Jankowski, J., Hunt, R.[2021]

Aspirin chemoprophylaxis, while potentially reducing colorectal cancer risk by 30%, was found to be non-cost-effective as an adjunct to screening methods like sigmoidoscopy or colonoscopy, leading to increased costs and fewer life-years gained due to complications.

The study suggests that aspirin should not replace colorectal cancer screening, and public health efforts should prioritize improving adherence to screening protocols rather than relying on aspirin for cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin as an adjunct to screening for prevention of sporadic colorectal cancer. A cost-effectiveness analysis. Ladabaum, U., Chopra, CL., Huang, G., et al.[2019]

Citations

1. 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.

2. 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.

3. 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- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1047279723001163

Low-dose acetylsalicylic acid for cancer prevention ... Conclusions. Our results suggest that aspirin intake is associated with a reduced incidence of colorectal, pancreatic, and prostate cancers and lymphomas.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559923/

Effectiveness of aspirin in the prevention of colorectal cancer ... However, this data showed a dose response effect: longer use of aspirin (5 or more years) showed lower rates of colorectal cancer than shorter use of aspirin (1 ...

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

Aspirin after completion of standard adjuvant therapy for ... Aspirin 200 mg daily for 3 years after completion of standard adjuvant therapy was well tolerated but did not significantly improve disease-free survival.

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2791401

Aspirin Use to Prevent Cardiovascular Disease and ... Low-dose aspirin was associated with a significant decrease in major cardiovascular disease events (odds ratio [OR], 0.90 [95% CI, 0.85-0.95]; ...