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

NCT ID: NCT00473980

Last Updated: 2012-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug

Treatment with indomethacin or celecoxib

Group Type EXPERIMENTAL

Indomethacin, celecoxib, esomeprazole

Intervention Type DRUG

SHAM

Sham treatment

Group Type SHAM_COMPARATOR

Indomethacin, celecoxib, esomeprazole

Intervention Type DRUG

Interventions

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Indomethacin, celecoxib, esomeprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Colon carcinoma scheduled for curative operation

Exclusion Criteria

* Diabetes, steroid medication, liver and kidney impairment
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Principal Investigators

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Kent Lundholm, MD, prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Department of Surgery

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Related Links

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http://www.gu.se

Göteborg University

Other Identifiers

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kl4501122

Identifier Type: -

Identifier Source: org_study_id

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