Can aspirin timing stop colon cancer?
NCT ID NCT02965703
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study looks at whether taking aspirin in different patterns can help prevent colorectal cancer in people who have had colon polyps (adenomas). Aspirin may block certain enzymes that help cancer cells grow. The trial enrolled 81 adults with a history of colon polyps and measured changes in cell growth and death markers in the colon lining.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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81 people
The number who actually took part.
- Started
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Jan 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of colorectal adenoma of any grade * Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Leukocytes \>= 3,000/microliter * Absolute neutrophil count \>= 1,500/microliter * Platelets \>= 150,000/microliter * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * 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 * Blood hemoglobin \>= 12.0 g/dL * Alkaline phosphatase =\< 1.5 x institutional ULN * Blood urea nitrogen (BUN) =\< 40 mg/dL * Estimated glomerular filtration rate (eGFR) \>= 45 mL/min * Negative fecal occult blood test * The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * Ability to understand and the willingness to sign a written informed consent document 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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