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Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer

Ductal Breast Carcinoma in Situ Clinical Trial

Official title:
Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial

Clinical Trial Summary

This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

i.) To determine whether nanoemulsion curcumnin modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.

SECONDARY OBJECTIVES include:

ii.) To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;

iii.) Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.

iv.) Explore additional biomarkers as surrogate endpoints to measure effects of NEC.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive lower dose of nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.

ARM II: Participants receive 100 mg of nanoemulsion curcumin PO BID for 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01975363
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date September 19, 2016
View Details
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