NCT02141139

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,568

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

October 21, 2013

Last Update Submit

May 14, 2014

Conditions

Breast Neoplasms

Keywords

Anti-Inflammatory Agents, Non-SteroidalInflammationPerioperative Period

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    5 years

Secondary Outcomes (1)

  • overall survival

    5years

Other Outcomes (1)

  • neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP)

    POD 1-2 weeks (immediate postoperative period)

Study Arms (2)

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

NSAIDS (ketorolac and ibuprofen)DRUG
NSAIDS (ketorolac intravenous, ibuprofen)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patients who took the surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammation

Interventions

Anti-Inflammatory Agents, Non-SteroidalKetorolacIbuprofen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Se Kyung Lee, M.D.

CONTACT

82-10-3014-0110sekyung.lee@samsung.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2013

First Posted

May 19, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Last Updated

May 19, 2014

Record last verified: 2014-05

Locations

KR(1)