Perioperative Inflammation and Breast Cancer Outcome

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02141139
• Collaborator: (none)
• Enrollment: 1,568
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: NSAIDS (ketorolac and ibuprofen)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1568 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control arm no medication or acetaminophen
Experimental: NSAIDS (ketorolac intravenous, ibuprofen) ketorolac IV (just before surgery) and ibuprofen for 1 weeks	Drug: NSAIDS (ketorolac and ibuprofen)

Outcome Measures

Primary Outcome Measures

1. disease free survival [5 years]

Secondary Outcome Measures

1. overall survival [5years]

Other Outcome Measures

1. neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP) [POD 1-2 weeks (immediate postoperative period)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seok Jin Nam, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02141139
• Other Study ID Numbers: 2009-11-036
• First Posted: May 19, 2014
• Last Update Posted: May 19, 2014
• Last Verified: May 1, 2014

• Keywords provided by Seok Jin Nam, Professor, Samsung Medical Center: Anti-Inflammatory Agents, Non-Steroidal; Inflammation; Perioperative Period
• Additional relevant MeSH terms: Breast Neoplasms; Inflammation; Ibuprofen; Ketorolac

Study Results

No Results Posted as of May 19, 2014