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

Göteborg University

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: Indomethacin, celecoxib, esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00473980

kl4501122

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colon carcinoma scheduled for curative operation

Exclusion criteria

• Diabetes, steroid medication, liver and kidney impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Drug

Experimental group

Description:

Treatment with indomethacin or celecoxib

Treatment:

Drug: Indomethacin, celecoxib, esomeprazole

SHAM

Sham Comparator group

Description:

Sham treatment

Treatment:

Drug: Indomethacin, celecoxib, esomeprazole