Perioperative Inflammation and Breast Cancer Outcome

Phase 3

• Conditions: Breast Neoplasms
• Interventions: Drug: NSAIDS (ketorolac and ibuprofen)

• Registration Number: NCT02141139
• Lead Sponsor: Samsung Medical Center

Brief Summary

It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Therefore, we want to know the association between prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-21
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Study First Posted: 2014-05-19
• Last Update Posted: 2014-05-19
• Study Start: 2014-09
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1568

Inclusion Criteria

• Breast cancer patients who took the surgery

Exclusion Criteria

• underlying medical disease (major heart disease, lung disease, coagulopathy)
• major psychologic disease (major depression, schizophrenia, manic disorder)
• pregnancy
• rheumatic disease patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NSAIDS (ketorolac intravenous, ibuprofen)	NSAIDS (ketorolac and ibuprofen)	ketorolac IV (just before surgery) and ibuprofen for 1 weeks

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years

Secondary Outcome Measures

Name	Time	Method
overall survival	5years

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of