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

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Indomethacin, celecoxib, esomeprazole

• Registration Number: NCT00473980
• Lead Sponsor: Göteborg University

Brief Summary

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

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 Timeline

• Study Start: 1998-12
• Study Completion: 2007-05
• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-16
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Colon carcinoma scheduled for curative operation

Exclusion Criteria

• Diabetes, steroid medication, liver and kidney impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	Indomethacin, celecoxib, esomeprazole	Treatment with indomethacin or celecoxib
SHAM	Indomethacin, celecoxib, esomeprazole	Sham treatment

Primary Outcome Measures

Name	Time	Method
Immune reactivity	Acute evaluations

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Göteborg, Sweden