Preoperative NSAID to Colorectal Cancer Patients - Full Text View

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

Genetics Home Reference related topics:

Colorectal Cancer

MedlinePlus related topics:

Colorectal Cancer

ChemIDplus related topics:

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
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:

Celecoxib

Digestive System Neoplasms

Gastrointestinal Diseases

Indomethacin

Colonic Diseases

Omeprazole

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Colorectal Neoplasms

Carcinoma

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

Digestive System Diseases

Tocolytic Agents

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Anti-Ulcer Agents

Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 08, 2008

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