Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
NCT ID: NCT01975363
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2013-06-30
2016-09-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
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.
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.
curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
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.
Interventions
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curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
FEMALE
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Steven Clinton
Principal Investigator
Principal Investigators
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Steven Clinton, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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Related Links
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Jamesline
Other Identifiers
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NCI-2013-01199
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-13034
Identifier Type: -
Identifier Source: org_study_id
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