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 Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether aspirin can help prevent colorectal cancer in individuals with colorectal adenoma. The study will determine if aspirin can inhibit tumor cell growth by blocking certain necessary enzymes. Participants will be divided into groups to receive either aspirin, a combination of aspirin and a placebo (a harmless pill), or just a placebo. Individuals diagnosed with colorectal adenoma who are not taking certain medications or have specific health conditions may be suitable candidates. As a Phase 2 trial, this research measures aspirin's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that aspirin is likely to be safe for humans?

Research has shown that aspirin is generally safe for use. Studies have found that taking low-dose aspirin can reduce the risk of developing colorectal cancer. Specifically, one study found that using aspirin for about 20 years lowered this risk by 41%. Aspirin is commonly used and often recommended for other health issues, such as heart disease, which supports its safety profile. Most people do not experience serious side effects from aspirin, but following dosage instructions is important to avoid any problems. For those considering joining a trial, knowing that aspirin is a common and generally safe medication might be reassuring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about using aspirin to prevent colorectal cancer in patients with adenomas because it offers a potentially simple and cost-effective prevention strategy. Unlike the standard treatments that often involve more invasive procedures or medications with significant side effects, aspirin is a widely available and well-tolerated over-the-counter medication. Aspirin's potential anti-inflammatory and anti-cancer effects could offer an accessible option for reducing the risk of cancer development in these patients. The trial explores different dosing schedules, including continuous and intermittent aspirin use, which might optimize its effectiveness and minimize side effects.

What evidence suggests that aspirin might be an effective treatment for preventing colorectal cancer in patients with adenomas?

Research has shown that aspirin can help prevent colorectal cancer in people with colorectal adenomas. Studies indicate that a daily aspirin dose as low as 325 mg can lower the risk of developing this cancer type. Using aspirin for more than 5 years has been linked to reduced cancer rates. In this trial, participants in Arm I will receive aspirin daily, those in Arm II will receive aspirin intermittently with a placebo, and Arm III will receive a placebo only. Specifically, one study found that patients taking aspirin were 55% less likely to experience cancer recurrence compared to those taking a placebo. This finding suggests that aspirin might help stop tumor growth by blocking certain enzymes needed for cell growth. ^{1 6 7 8 9}

Who Is on the Research Team?

Qi Dai

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

I am mostly self-sufficient and can carry out daily activities.

Leukocytes >= 3,000/microliter

Absolute neutrophil count >= 1,500/microliter

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm II (aspirin, placebo) Experimental Treatment 5 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 Treatment 4 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 Group 4 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:

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?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3354696/

Aspirin for the prevention of colorectal cancer - PubMed Central Taking clinical trial and observational data together, there is clear evidence that aspirin in doses as low as 325 mg per day reduces CRC risk.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa021735

A Randomized Trial of Aspirin to Prevent Colorectal ... Extensive observational data strongly suggest that persistent aspirin use reduces the risk of colorectal neoplasia. Although 10 to 20 years of treatment seem to ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559923/

Effectiveness of aspirin in the prevention of colorectal cancer ... However, this data showed a dose response effect: longer use of aspirin (5 or more years) showed lower rates of colorectal cancer than shorter use of aspirin (1 ...

4. asco.org asco.org/about-asco/press-center/news-releases/new-findings-aspirin-and-risk-colorectal-cancer-recurrence

Aspirin May Reduce Risk of Colorectal Cancer Recurrence ... For Group A and Group B combined, patients who took aspirin were 55% less likely to have their cancer recur than those who took a placebo.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.17_suppl.LBA3511

Aspirin as secondary prevention for colorectal cancer liver ... The probability of surviving past 36 months was 76.1% in the aspirin group and 84.9% in the placebo group, with an overall survival HR of 1.60 ( ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S246829422500022X

Role of aspirin in cancer prevention The results showed that the use of low-dose aspirin was associated with a reduced risk of colorectal cancer during a mean follow-up of 10.9 years (hazard ratio ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208058/

Low-Dose Aspirin and Prevention of Colorectal Cancer We found a 13% lower CRC risk associated with current low-dose aspirin use vs never use, consistent with the findings of a recent large nested case-control ...

8. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/5/2/164/50062/Aspirin-in-the-Chemoprevention-of-Colorectal

Aspirin in the Chemoprevention of Colorectal Neoplasia An analysis of 9,232 men from 11 case–control studies reported that aspirin use (about 20 years) reduced the risk of CRC by 41% (RR, 0.59; 95% CI, 0.54–0.64; ...

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2775175

Aspirin Use and Risk of Colorectal Cancer Among Older ... Regular use of aspirin at or after age 70 years was associated with a lower risk of colorectal cancer compared with nonregular use.