Perioperative Inflammation and Breast Cancer Outcome

May 14, 2014 updated by: Seok Jin Nam, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1568

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5years
5years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-11-036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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