NCT01975363

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atypical Ductal Breast Hyperplasia
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Ductal Breast Carcinoma in Situ
• Lobular Breast Carcinoma in Situ

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	curcumin	Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
OTHER	Biomarker analysis	Breast adipose tissue and plasma samples will be obtained at baseline and 3 months for biomarker analyses. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin/COG and also stored at -80°C for biomarker analyses.
OTHER	Assessment of Dietary Intake	Food frequency questionnaires will be obtained at 0 months and 24-hour dietary recalls will be obtained at 1, 2 and 3 months of the study.
OTHER	Daily Log	All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-09-19
• Completion: 2016-09-19
• First posted: 2013-11-04
• Last updated: 2019-08-30

Locations

1 site across 1 country: United States