Perioperative Inflammation and Breast Cancer Outcome

Breast Neoplasms Clinical Trial

Official title:

Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02141139
• Other study ID #: 2009-11-036
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 21, 2013
• Last updated: May 14, 2014
• Start date: September 2014

Study information

• Verified date: May 2014
• Source: Samsung Medical Center
• Contact: Se Kyung Lee, M.D.
• Phone: 82-10-3014-0110
• Email: sekyung.lee[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1568
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Inflammation

Intervention

Drug:
• NSAIDS (ketorolac and ibuprofen)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP)		POD 1-2 weeks (immediate postoperative period)	No
Primary	disease free survival		5 years	Yes
Secondary	overall survival		5years	Yes