Perioperative Inflammation and Breast Cancer Outcome

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: NSAIDS (ketorolac and ibuprofen)

Study type: Interventional

Funder types: Other

Identifiers

NCT02141139

2009-11-036

Details and patient eligibility

About

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.

Enrollment: 1,568 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,568 participants in 2 patient groups

Control arm

No Intervention group

Description:

no medication or acetaminophen

NSAIDS (ketorolac intravenous, ibuprofen)

Experimental group

Description:

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

Treatment:

Drug: NSAIDS (ketorolac and ibuprofen)