Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients

Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions

The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Indomethacin, celecoxib, esomeprazole

Detailed Description

Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, SE 41345
    • Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Colon carcinoma scheduled for curative operation

Exclusion Criteria:

• Diabetes, steroid medication, liver and kidney impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug; Treatment with indomethacin or celecoxib	Drug: Indomethacin, celecoxib, esomeprazole
Sham Comparator: SHAM; Sham treatment	Drug: Indomethacin, celecoxib, esomeprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immune reactivity	Acute evaluations

Collaborators and Investigators

• Sponsor: Göteborg University

Publications and helpful links

Helpful Links

• Göteborg University

Study record dates

Study Major Dates

• Study Start: December 1, 1998
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: May 15, 2007
• First Submitted That Met QC Criteria: May 15, 2007
• First Posted (Estimate): May 16, 2007

Study Record Updates

• Last Update Posted (Estimate): April 2, 2012
• Last Update Submitted That Met QC Criteria: March 30, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Survival; NSAID; CTLs; Colon carcinoma; MHC
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Reproductive Control Agents; Cyclooxygenase 2 Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Gout Suppressants; Tocolytic Agents; Celecoxib; Indomethacin; Esomeprazole
• Other Study ID Numbers: kl4501122