← Back to Search

Nonsteroidal Anti-inflammatory Drug

Aspirin for Preventing Colorectal Cancer in Patients With Adenomas

Phase 2

Waitlist Available

Led By Qi Dai

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Diagnosis of colorectal adenoma of any grade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 9, and 12 weeks

Summary

This trial will test how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues like stomach pain and bleeding, allergic reactions, anemia due to potential bleeding risks, and possibly increased bruising or bleeding if there's interaction with other drugs.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I have been diagnosed with a type of colon polyp called adenoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 9, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 9, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 9, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Fecal occult blood test (measures of adverse events) as measured by stool samples

Ratio of cell proliferation (Ki-67)/apoptosis (TdT-mediated dUTP nick end labeling [TUNEL]) in rectal biopsies

Ratio of cell proliferation (Ki-67)/necroptosis (MLKL) in rectal biopsies

Other study objectives

Escherichia coli

BCL2-Associated X Protein (BAX) in rectal biopsies

COX-2 in rectal biopsies

+4 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

Biospecimen Collection

2004

Completed Phase 3

~2020