Aspirin for Colorectal Cancer Prevention

(ASPIRED Trial)

Overseen by Andrew Chan, MD, Ph.D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

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

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.

I am between 18 and 80 years old.

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.

Treatment Details

Interventions

• Aspirin (Nonsteroidal Anti-inflammatory Drug)
• Placebo for Aspirin (Other)

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 Canada, China for the following indications:

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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School