Perioperative Inflammation and Breast Cancer Outcome | NCT02141139

Studies
Perioperative Inflammation and Breast Cancer Outcome

NCT02141139

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

May 19, 2014Estimated

Enrollment

1,568Estimated

Phase

Phase 3

Conditions

Breast Neoplasms

Interventions

NSAIDS (ketorolac and ibuprofen)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 21, 2013

First Submission Date that Met QC Criteria

May 14, 2014

First Posted Date

May 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2014

Last Update Posted Date

May 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,568Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control arm	No Intervention	no medication or acetaminophen
NSAIDS (ketorolac intravenous, ibuprofen)	Experimental	ketorolac IV (just before surgery) and ibuprofen for 1 weeks	Drug: NSAIDS (ketorolac and ibuprofen)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NSAIDS (ketorolac and ibuprofen)	Drug		NSAIDS (ketorolac intravenous, ibuprofen)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease free survival		5 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival		5years

Other Outcomes

Measure	Description	Time Frame
neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP)		POD 1-2 weeks (immediate postoperative period)

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Se Kyung Lee, M.D.	Contact	82-10-3014-0110		sekyung.lee@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D007249	Inflammation

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000894	Anti-Inflammatory Agents, Non-Steroidal
D020910	Ketorolac
D007052	Ibuprofen

Ancestor Terms

ID	Term
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents

Browse Leaves

Not provided

Browse Branches

Not provided