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

Trial Summary

What is the purpose of this trial?

This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer. The name of the study intervention involved in this study is: * Low Dose Aspirin

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.

What data supports the effectiveness of the drug aspirin for colorectal cancer?

Research shows that aspirin use is linked to lower death rates from colorectal cancer and overall mortality, especially in patients with certain types of tumors. However, more studies are needed to confirm the best way to use aspirin for this purpose. ^{1 2 3 4 5}

Is aspirin safe for use in humans?

Aspirin is generally safe for humans but can cause gastrointestinal issues like stomach ulcers and bleeding, especially with long-term use. It may also increase the risk of bleeding strokes. These risks should be weighed against its benefits, particularly in preventing colorectal cancer. ^{4 6 7 8 9}

How does the drug aspirin differ from other treatments for colorectal cancer?

Aspirin is unique in its ability to reduce the risk of colorectal cancer by inhibiting prostaglandins, which are often elevated in cancer tissues, and it may also help prevent cancer spread and improve survival, especially in certain genetic tumor types. Unlike other treatments, aspirin is used both for primary prevention in high-risk individuals and as a secondary prevention to improve outcomes after diagnosis, although it carries a risk of bleeding. ^{1 4 10 11 12}

Research Team

Andrew Chan, MD, Ph.D

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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 am either between 18 and 55 years old or 65 years and older.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Aspirin: anticolorectal adenocarcinoma activity in the adjuvant arena? [2010]

2. England pubmed.ncbi.nlm.nih.gov

The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial. [2022]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

Low-dose aspirin use and survival in colorectal cancer: results from a population-based cohort study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effect of aspirin on the diagnostic accuracy of the faecal immunochemical test for colorectal advanced neoplasia. [2022]

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

Use and safety of aspirin in the chemoprevention of colorectal cancer. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Aspirin promotes apoptosis in a murine model of colorectal cancer by mechanisms involving downregulation of IL-6-STAT3 signaling pathway. [2021]

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

Aspirin, cyclooxygenase inhibition and colorectal cancer. [2021]

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

Suppression of human colorectal mucosal prostaglandins: determining the lowest effective aspirin dose. [2019]

11. England pubmed.ncbi.nlm.nih.gov

New use of low-dose aspirin and risk of colorectal cancer by stage at diagnosis: a nested case-control study in UK general practice. [2018]

12. France pubmed.ncbi.nlm.nih.gov

[Aspirin and colorectal cancer]. [2018]