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NCT00473980 Clinical Trial

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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00473980
Other study ID # kl4501122
Secondary ID
Status Completed
Phase Phase 4
First received May 15, 2007
Last updated March 30, 2012
Start date December 1998
Est. completion date May 2007

Study information
Verified date March 2012
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Colon carcinoma scheduled for curative operation

Exclusion Criteria:

- Diabetes, steroid medication, liver and kidney impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indomethacin, celecoxib, esomeprazole

Locations
Country Name City State
Sweden Department of Surgery Göteborg

Sponsors (1)
Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune reactivity Acute evaluations
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