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Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

81 Participants Needed

Aspirin for Preventing Colorectal Cancer in Patients With Adenomas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: NSAIDs, Anticoagulants, Corticosteroids, others

Disqualifiers: Invasive malignancy, Renal diseases, others

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including aspirin, other NSAIDs (nonsteroidal anti-inflammatory drugs), COX-2 inhibitors, anticoagulants, anti-platelet agents, corticosteroids, and methotrexate, at least three weeks before joining the study.

What evidence supports the effectiveness of aspirin in preventing colorectal cancer in patients with adenomas?

Research shows that aspirin can reduce the recurrence of colorectal adenomas (small growths that can turn into cancer) and lower the risk of developing colorectal cancer. Studies have found that regular use of low-dose aspirin is linked to a decrease in colorectal cancer incidence and mortality, especially in patients with certain types of tumors.¹ ² ³ ⁴ ⁵

Is aspirin safe for preventing colorectal cancer in patients with adenomas?

Aspirin has been shown to reduce the risk of colorectal cancer, but it can cause significant side effects, including gastrointestinal issues like bleeding and ulcers, and an increased risk of hemorrhagic strokes, especially with long-term use.² ³ ⁶ ⁷ ⁸

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

Aspirin is unique in its ability to prevent colorectal cancer by inhibiting the cyclooxygenase (COX) pathway, which reduces the formation of adenomas (precancerous polyps) and lowers cancer risk. Unlike other treatments, aspirin is a common, everyday drug that can be used at low doses for long-term chemoprevention, although it carries a risk of bleeding, especially in the gastrointestinal tract.³ ⁵ ⁹ ¹⁰ ¹¹

What is the purpose of this trial?

This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Qi Dai

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults with colorectal adenoma who are in good health, with specific blood and organ function criteria met. They must not have had invasive cancer in the past 2 years (except non-melanoma skin cancer), no chronic kidney or liver diseases, and not be on certain medications like NSAIDs or anticoagulants. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN

Creatinine =< 1.5 x institutional ULN

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

See 12 more

Exclusion Criteria

Current (within three weeks of randomization) or planned use during the study intervention of the following: Aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or COX-2 inhibitors; Anticoagulants, anti-platelet agents, or corticosteroids; Gingko; Ethanol consumption > 1 standard drinks/day for women, or > 2 standard drinks/day for men; Methotrexate (MTX); Study participants will be instructed to use Tylenol or some other non-excluded agent to treat common ailments (i.e. headache/minor aches and pains)

History of any invasive malignancy within the past 2 years, with the exception of non-melanoma skin cancer; Chronic renal diseases or liver cirrhosis; Diseases such as anemia, peptic ulcer, gastrointestinal bleeding, active colitis and inflammatory bowel disease; Hemorrhagic stroke or uncontrolled hypertension; Participants may not be receiving any other investigational agents; History of allergic reactions or intolerance attributed to aspirin or compounds of similar chemical or biologic composition; Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements; Women who are pregnant or breastfeeding; pregnant women are excluded from this study because aspirin has the potential for abortifacient effects; because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with aspirin, breastfeeding should be discontinued if the mother is treated with aspirin

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aspirin or placebo for 12 weeks, with sample collections throughout the trial

12 weeks

Regular visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

Aspirin

Trial Overview The study is testing if aspirin can prevent colorectal cancer in patients with colorectal adenomas by inhibiting enzymes needed for tumor growth. It involves taking aspirin versus a placebo, along with biospecimen collection, questionnaires, and rectal biopsies to assess effectiveness.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm II (aspirin, placebo)Experimental Treatment5 Interventions

Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Group II: Arm I (aspirin)Experimental Treatment4 Interventions

Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Group III: Arm III (placebo)Placebo Group4 Interventions

Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Aspirin is already approved in European Union, United States, Canada, China for the following indications: