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Nonsteroidal Anti-inflammatory Drug

Aspirin for Colorectal Cancer Prevention (ASPIRED Trial)

N/A

Waitlist Available

Led By Andrew T Chan, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently taking aspirin (any dose) within the last 6 months

Age 18-80 years

Must not have

Any adenoma that was not completely removed during previous colonoscopy

Participant must be able to swallow pills

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-12 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing whether aspirin can help prevent colorectal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Aspirin may cause side effects such as increased risk of bleeding, allergic reactions for those sensitive to it, digestive issues like ulcers or gastrointestinal bleeds especially if there's a history of intolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 80 years old.

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

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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I can swallow pills.

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

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I have been diagnosed with FAP or Lynch Syndrome.

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I have a history of issues with aspirin, bleeding disorders, stomach ulcers, GI bleeds, problems with endoscopy, or reasons I can't have a colonoscopy.

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I am currently taking blood thinners.

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I have used NSAIDs (not aspirin) regularly for the last 2 months.

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I cannot or will not stop taking aspirin/NSAIDs or provide samples during the study.

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I haven't had treatment for any cancer, including gastrointestinal, in the last 3 years.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Urinary Prostaglandin Metabolites (PGE-M)

Secondary study objectives

Chromatin Binding

Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)

Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Low Dose AspirinActive Control1 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 AspirinActive Control1 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 Group1 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.

0 / 14Eligibility criteria met