Phase 2 N=79 Randomized Double-blind Prevention

Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer

Colon Cancer · Precancerous Condition · Rectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00468910 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months. — 40.72; 37.54; 43.45; 37.52 micron^-1 — p=0.11

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: acetylsalicylic acid (Drug); placebo (Drug); laboratory biomarker analysis (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.	40.72; 37.54; 43.45; 37.52	0.11
PRIMARY Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.	142.41; 23.28; -407.78; 650.97	0.17
SECONDARY Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3	4.56; 5.24; 4.26; 7.26	—
SECONDARY Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67	38.07; 40.45; 43.60; 37.74	—
SECONDARY Rectal Prostaglandin Levels as Measured by ELISA	305.93; 654.64; 211.97; 209.02	—

Summary

This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.

Eligibility Criteria

Criteria:

No active or metastatic cancer within the past 6 months
Scheduled to undergo colonoscopy for colonic neoplasia surveillance
Hemoglobin >= 12.0 g/dL
Platelet count >= 120,000/mm^3
AST or ALT = = 45 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No coagulopathy
No anemia
No history of peptic ulcer disease or gastrointestinal hemorrhage
No history of cerebrovascular accident
No uncontrolled hypertension
No history of intolerance or allergy to aspirin or to NSAIDs
No liver disease as manifested by signs or symptoms of cirrhosis
No endoscopic or radiographic evidence of portal hypertension
No active colitis by endoscopy
No history of inflammatory bowel disease
No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or transient ischemic attack)
No untreated helicobacter pylori infection
History of significant colonic neoplasia, defined as 1 of the following:
Adenoma within the past 6 years
Colorectal cancer within the past 6 years
Known adenoma on present exam
Histologically confirmed polyps seen on imaging
INR =< 1.5
At least 6 months since prior cancer treatment
No other concurrent acetylsalicylic acid (aspirin)-containing products or non-steroidal anti-inflammatory drugs (NSAIDs)
No concurrent systemic corticosteroids
No other concurrent anticoagulants or antiplatelet agents
No concurrent investigational drugs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00468910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.