Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

NCT02965703 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 6 other identifiers: NCI-2016-01642N01-CN-2012-00035NCI2015-06-01NWU2015-06-01N01CN00035P30CA060553
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Adenoma; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)

  Change in the ratio of proliferation to apoptosis biomarkers (Ki67 density index: BAX density index, measured continuously after IHC staining) in colorectal mucosa of compliant participants

  Baseline to end of intervention up to 12 weeks

Secondary Outcomes (3)

• Ratio of Cell Proliferation (Ki-67)/Apoptosis (TdT-mediated dUTP Nick End Labeling [TUNEL]) in Rectal Biopsies

  Baseline to end of intervention up to 12 weeks

• Ratio of Cell Proliferation (Ki-67)/Necroptosis (MLKL) in Rectal Biopsies

  Baseline to end of intervention up to 12 weeks

• Fecal Occult Blood Test (Measures of Adverse Events) as Measured by Stool Samples

  Baseline to end of intervention up to 12 weeks.

Study Arms (3)

Arm I (aspirin)

EXPERIMENTAL

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.

Drug: Aspirin; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Procedure: Rectal Biopsy

Arm II (aspirin, placebo)

EXPERIMENTAL

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.

Drug: Aspirin; Procedure: Biospecimen Collection; Other: Placebo Administration; Other: Questionnaire Administration; Procedure: Rectal Biopsy

Arm III (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biospecimen Collection; Other: Placebo Administration; Other: Questionnaire Administration; Procedure: Rectal Biopsy

Interventions

Aspirin DRUG

Given PO

Also known as: Acetylsalicylic Acid, ASA, Aspergum, Ecotrin, Empirin, Entericin, Extren, Measurin

Arm I (aspirin); Arm II (aspirin, placebo)

Biospecimen Collection PROCEDURE

Undergo collection of blood, urine, stool, and rectal swab samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm I (aspirin); Arm II (aspirin, placebo); Arm III (placebo)

Placebo Administration OTHER

Given PO

Arm II (aspirin, placebo); Arm III (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (aspirin); Arm II (aspirin, placebo); Arm III (placebo)

Rectal Biopsy PROCEDURE

Undergo rectal biopsy

Also known as: Biopsy of Rectum

Arm I (aspirin); Arm II (aspirin, placebo); Arm III (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Aspirin; Specimen Handling

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Dr. Seema A. Khan
• Organization: Northwestern University

s-khan2@northwestern.edu

312-503-4236

Study Officials

• Qi Dai

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 17, 2016
• Study Start: January 16, 2018
• Primary Completion: January 31, 2023
• Study Completion (Estimated): December 24, 2026
• Last Updated: May 28, 2026
• Results First Posted: March 4, 2025

Record last verified: 2026-02

Locations

US (1)