Back to resultsPerioperative Inflammation and Breast Cancer Outcome
Primary Purpose
Breast Neoplasms
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NSAIDS (ketorolac and ibuprofen)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Anti-Inflammatory Agents, Non-Steroidal, Inflammation, Perioperative Period
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
NSAIDS (ketorolac intravenous, ibuprofen)
Arm Description
no medication or acetaminophen
ketorolac IV (just before surgery) and ibuprofen for 1 weeks
Outcomes
Primary Outcome Measures
disease free survival
Secondary Outcome Measures
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02141139
Brief Title
Perioperative Inflammation and Breast Cancer Outcome
Official Title
Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Anti-Inflammatory Agents, Non-Steroidal, Inflammation, Perioperative Period
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1568 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
no medication or acetaminophen
Arm Title
NSAIDS (ketorolac intravenous, ibuprofen)
Arm Type
Experimental
Arm Description
ketorolac IV (just before surgery) and ibuprofen for 1 weeks
Intervention Type
Drug
Intervention Name(s)
NSAIDS (ketorolac and ibuprofen)
Primary Outcome Measure Information:
Title
disease free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5years
Other Pre-specified Outcome Measures:
Title
neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP)
Time Frame
POD 1-2 weeks (immediate postoperative period)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Se Kyung Lee, M.D.
Phone
82-10-3014-0110
Email
sekyung.lee@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Kyung Lee, M.D.
Phone
82-10-3014-0110
Email
sekyung.lee@samsung.com
12. IPD Sharing Statement
Learn more about this trial
Perioperative Inflammation and Breast Cancer Outcome
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