Preoperative NSAID to Colorectal Cancer Patients - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Preoperative Treatment With NSAID in Colorectal Cancer Patients in Relationship to Tumor Host Reactions

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Indomethacin Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Celecoxib

U.S. FDA Resources

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

Additional Information:

Göteborg University This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Göteborg University:

MHC
CTLs
Colon carcinoma
NSAID
Survival

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Indomethacin
Celecoxib
Omeprazole

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012