NCT02965703

Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To test for the equivalency of the two aspirin schedules. SECONDARY OBJECTIVES: I. To evaluate the effects of aspirin treatments on: Ia. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples. EXPLORATORY OBJECTIVES: I. To evaluate the effects of aspirin treatments on: Ia. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A \[cell cycle regulation\], MGMT \[deoxyribonucleic acid (DNA) repair\], DAPK1 \[apoptosis\], CDH1 \[cell invasion\], WNT16 \[Wnt pathway\] and RASSF1 \[RAS signaling\]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive aspirin orally (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. ARM II: 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. ARM III: 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. After completion of study, patients are followed up at 1 month.

Conditions

• Colorectal Adenoma
• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Aspirin	Given PO
PROCEDURE	Biospecimen Collection	Undergo collection of blood, urine, stool, and rectal swab samples
OTHER	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Rectal Biopsy	Undergo rectal biopsy

Timeline

• Start date: 2018-01-16
• Primary completion: 2023-01-31
• Completion: 2026-12-24
• First posted: 2016-11-17
• Last updated: 2026-04-13
• Results posted: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study