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

NCT00468910 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2009-00841CDR0000652929NCI 04-2-03NWU04-2-03N01CN35157
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Precancerous Condition; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.

  Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. SPEC characterizes the size distribution of macromolecular complexes and other intracellular structures, with a decrease of the spectral slope implying a shift of the size distribution of intracellular structures toward smaller sizes. Spectral markers SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture.

  3 months from baseline colonoscopy to end of intervention.

• Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months.

  Spectral marker assessment was performed via LEBS analysis (low-coherence enhanced backscattering spectroscopy) on the uninvolved mucosal biopsies of subjects taken at baseline and after 3 months of treatment with either aspirin or placebo. FRAC characterizes the spatial autocorrelation function of mass density distribution in tissue. SPEC and FRAC provide a measure of the fundamental characteristics of the tissue nanoscale architecture

  3 months from baseline colonoscopy to end of intervention.

Secondary Outcomes (3)

• Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3

  3 months from baseline colonoscopy to end of intervention.

• Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67

  3 months from baseline colonoscopy to end of intervention.

• Rectal Prostaglandin Levels as Measured by ELISA

  3 months from baseline colonoscopy to end of intervention.

Other Outcomes (1)

• Platelet Cyclooxygenase (COX) Activity as Measured by a Peroxidase-based COX Enzyme Activity Assay

  3 months from baseline colonoscopy to end of intervention.

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral acetylsalicylic acid (aspirin) once daily.

Drug: acetylsalicylic acid; Other: laboratory biomarker analysis

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily.

Drug: placebo; Other: laboratory biomarker analysis

Interventions

acetylsalicylic acid DRUG

Given orally

Also known as: ASA, Ecotrin, Empirin, Extren

Arm I

placebo DRUG

Given orally

Also known as: PLCB

Arm II

laboratory biomarker analysis OTHER

Correlative study

Arm I; Arm II

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 =\< 1.5 times upper limit of normal (ULN) * Alkaline phosphatase =\< 1.5 times ULN * Bilirubin =\< 1.5 times ULN * BUN =\< 40 mg/dL * Glomerular filtration rate \>= 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Roy HK, Turzhitsky V, Wali R, Radosevich AJ, Jovanovic B, Della'Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez L, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2):285-292. doi: 10.1136/gutjnl-2015-309996. Epub 2015 Oct 26.

  PMID: 26503631 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Precancerous Conditions; Rectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; 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

Results Point of Contact

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

skhan@nm.org

312-503- 4236

Study Officials

• Hemant Roy

  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: May 2, 2007
• First Posted: May 3, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2011
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)