Clinical Trials Directory

Trials / Completed

CompletedNCT01881048

Window of Opportunity Study Targeting the Inflammatory Milieu

Window of Opportunity Study Targeting the Inflammatory Milieu of Pregnancy Associated Breast Cancer

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
42 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.

Detailed description

This randomized pilot clinical trial studies omega-3 fatty acid or celecoxib in treating patients with breast cancer planning to undergo surgery. Omega-3 fatty acid may stimulate the immune system in different ways and stop tumor cells from growing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether omega-3 fatty acid or celecoxib is more effective in treating breast cancer.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOmega-3 fatty acidGiven PO
DRUGCelecoxibGiven PO

Timeline

Start date
2009-12-08
Primary completion
2014-01-14
Completion
2015-12-14
First posted
2013-06-19
Last updated
2026-01-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01881048. Inclusion in this directory is not an endorsement.