The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer...
Date First Received: May 15, 2007
Last Updated: May 15, 2007
Verified by: Göteborg University, May 2007
Clinical Trial Phase: Phase 4 | Start Date: December 1998
Overall Status: Completed
Estimated Enrollment: 28
Brief Summary
Official Title: “Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions”
Condition Keyword(s):
Intervention(s):
The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Indomethacin, celecoxib, esomeprazole
Outcome Measures for this Clinical Trial
Primary Measures
- Immune reactivity
- Time Frame: Acute evaluations
- Time Frame: Acute evaluations
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Colon carcinoma scheduled for curative operation
Exclusion Criteria:
- Diabetes, steroid medication, liver and kidney impairment
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Göteborg University
Overall Clinical Trial Officials and Contacts
Kent Lundholm, MD, prof Principal Investigator Göteborg University
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00473980
Study ID Number: kl4501122
ClinicalTrials.gov Identifier: NCT00473980
Health Authority: Sweden: The National Board of Health and Welfare
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