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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is investigating the use of aspirin as a potential chemopreventive agent to reduce risk of 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.

What evidence supports the effectiveness of the drug aspirin for preventing colorectal cancer?

Research shows that taking aspirin daily can reduce the risk of colorectal cancer by 30-40% over 20 years and lower the chance of cancer-related death by about 20%. However, the best dose and duration for prevention are still unclear, and there are risks like bleeding to consider. ^{1 2 3 4 5}

Is aspirin safe for use in humans, particularly for colorectal cancer prevention?

Aspirin is generally considered safe for use in humans, but it can cause side effects like bleeding, especially in the stomach and intestines. Long-term use at low doses may reduce these risks, but careful monitoring is needed to avoid severe adverse effects. ^{3 6 7 8 9}

How does aspirin differ from other drugs for colorectal cancer prevention?

Aspirin is unique in colorectal cancer prevention because it not only reduces cancer risk but also provides cardiovascular benefits, unlike other non-steroidal anti-inflammatory drugs (NSAIDs) that do not offer cardioprotection. Its effectiveness is linked to its ability to inhibit COX-1 in platelets, which is central to its antitumor effects, and it has a well-established safety profile when used in low doses. ^{2 3 4 10 11}

Research Team

Andrew Chan, MD, Ph.D

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Aspirin and the prevention of colorectal cancer. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Aspirin in prevention of sporadic colorectal cancer: current clinical evidence and overall balance of risks and benefits. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Aspirin As Secondary Prevention in Patients With Colorectal Cancer: An Unselected Population-Based Study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Aspirin, cyclooxygenase inhibition and colorectal cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Adjuvant antiplatelet therapy with aspirin in colo-rectal cancer. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Cyclooxygenase-2 inhibitors in colorectal cancer prevention: counterpoint. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Aspirin for the prevention of colorectal cancer. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The role of aspirin in colorectal cancer chemoprevention. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Preventive effects of low-dose aspirin on colorectal adenoma growth in patients with familial adenomatous polyposis: double-blind, randomized clinical trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Aspirin as an adjunct to screening for prevention of sporadic colorectal cancer. A cost-effectiveness analysis. [2019]