- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Other Names:
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 Names:
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 Names:
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
|
Experimental: 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.
|
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Other Names:
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 Names:
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 Names:
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
Time Frame: Up to 3 months
|
Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
Time Frame: up to 3 months
|
up to 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Clinton, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma, Ductal
- Carcinoma in Situ
- Breast Neoplasms
- Carcinoma
- Hyperplasia
- Breast Carcinoma In Situ
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Lobular
- Carcinoma, Ductal, Breast
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- OSU-13034
- NCI-2013-01199 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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