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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00473980
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : April 2, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Indomethacin, celecoxib, esomeprazole Phase 4

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions
Study Start Date : December 1998
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Immune reactivity [ Time Frame: Acute evaluations ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Colon carcinoma scheduled for curative operation

Exclusion Criteria:

  • Diabetes, steroid medication, liver and kidney impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00473980

Department of Surgery
Göteborg, Sweden, SE 41345
Sponsors and Collaborators
Göteborg University
Principal Investigator: Kent Lundholm, MD, prof Göteborg University

Additional Information: Identifier: NCT00473980     History of Changes
Other Study ID Numbers: kl4501122
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by Göteborg University:
Colon carcinoma

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Gout Suppressants