Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (lower dose curcumin)
Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Biomarker analysis (Other)
Arm I (lower dose curcumin)
Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Assessment of Dietary Intake (Other)
Arm I (lower dose curcumin)
Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Daily Log (Other)
Arm II (higher dose curcumin)
Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Biomarker analysis (Other)
Arm II (higher dose curcumin)
Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Assessment of Dietary Intake (Other)
Arm II (higher dose curcumin)
Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: Daily Log (Other)
Arm II (higher dose curcumin)
Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: curcumin (Dietary Supplement)
Arm I (lower dose curcumin)
Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
干预措施: curcumin (Dietary Supplement)
结局指标
主要结局
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
时间窗: Up to 3 months
Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.
次要结局
- 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)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center