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

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00473980
First received: May 15, 2007
Last updated: March 30, 2012
Last verified: March 2012
  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 4

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:


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
Arms Assigned Interventions
Experimental: Drug
Treatment with indomethacin or celecoxib
Drug: Indomethacin, celecoxib, esomeprazole
Sham Comparator: SHAM
Sham treatment
Drug: Indomethacin, celecoxib, esomeprazole

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00473980     History of Changes
Other Study ID Numbers: kl4501122
Study First Received: May 15, 2007
Last Updated: March 30, 2012
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Esomeprazole
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Ulcer Agents
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014