Preoperative NSAID to Colorectal Cancer Patients - Full Text View

Sponsored by:	Göteborg University
Information provided by:	Göteborg University
ClinicalTrials.gov Identifier:	NCT00473980

Purpose

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

Condition	Intervention	Phase
Colorectal Cancer	Drug: Indomethacin, celecoxib, esomeprazole	Phase IV

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Indomethacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions

Further study details as provided by Göteborg University:

Primary Outcome Measures:

Immune reactivity [ Time Frame: Acute evaluations ]

Enrollment:	28
Study Start Date:	December 1998
Study Completion Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Colon carcinoma scheduled for curative operation

Exclusion Criteria:

Diabetes, steroid medication, liver and kidney impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473980

Locations

Sweden
Department of Surgery
Göteborg, Sweden, SE 41345

Sponsors and Collaborators

Göteborg University

Investigators

Principal Investigator:

Kent Lundholm, MD, prof

Göteborg University

More Information

Göteborg University This link exits the ClinicalTrials.gov site

Study ID Numbers:	kl4501122
Study First Received:	May 15, 2007
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00473980
Health Authority:	Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:

MHC
CTLs
Colon carcinoma
NSAID
Survival

Study placed in the following topic categories:

Digestive System Neoplasms
Celecoxib
Gastrointestinal Diseases
Colonic Diseases
Omeprazole
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Indomethacin
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Tocolytic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009