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 Details — Status: Completed

Administrative data

• NCT number: NCT01975363
• Other study ID #: OSU-13034
• Secondary ID: NCI-2013-01199
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 19, 2016

Study information

• Verified date: August 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 19, 2016
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

INCLUSION CRITERIA:

• Increased risk for breast cancer based on family history, personal history

• Normal mammogram, clinical breast examination in the past 12 months

• >1 year from pregnancy, lactation or chemotherapy

• Body mass index (BMI) between 25 - 40

EXCLUSION CRITERIA:

• Concurrent malignancy or metastatic malignancy of any kind

• Ongoing chemotherapy, radiation therapy, or other cancer-related treatment

• History of a bleeding tendency or current use of Coumadin or other anticoagulants

• Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection

• Pregnant or lactating women

• Concurrent use of hormonal contraception or hormone replacement therapy

• Concurrent use of immunosuppressant medications

• Concurrent use of medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4

• Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements

• Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC

• Known sensitivity or allergy to turmeric spices or curry

• Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis

• Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products

Related Conditions & MeSH terms

• Atypical Ductal Breast Hyperplasia
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Ductal Breast Carcinoma in Situ
• Hyperplasia
• Lobular Breast Carcinoma in Situ

Intervention

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.
• 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.
• Daily Log
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.	Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.	Up to 3 months
Secondary	Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.		up to 3 months

External Links

•   Jamesline