Perioperative Inflammation and Breast Cancer Outcome

NCT ID: NCT02141139

Last Updated: 2014-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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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

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

no medication or acetaminophen

Group Type NO_INTERVENTION

No interventions assigned to this group

NSAIDS (ketorolac intravenous, ibuprofen)

ketorolac IV (just before surgery) and ibuprofen for 1 weeks

Group Type EXPERIMENTAL

NSAIDS (ketorolac and ibuprofen)

Intervention Type DRUG

Interventions

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NSAIDS (ketorolac and ibuprofen)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seok Jin Nam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Se Kyung Lee, M.D.

Role: CONTACT

82-10-3014-0110

Facility Contacts

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Se Kyung Lee, M.D.

Role: primary

82-10-3014-0110

Other Identifiers

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2009-11-036

Identifier Type: -

Identifier Source: org_study_id

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