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

This study is currently recruiting participants.
Verified November 2016 by Lisa Yee, Ohio State University Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01975363
First Posted: November 4, 2013
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa Yee, Ohio State University Comprehensive Cancer Center
  Purpose
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.

Condition Intervention
Atypical Ductal Breast Hyperplasia BRCA1 Gene Mutation BRCA2 Gene Mutation Ductal Breast Carcinoma in Situ Lobular Breast Carcinoma in Situ Dietary Supplement: curcumin Other: Biomarker analysis Other: Assessment of Dietary Intake Other: Daily Log

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial

Resource links provided by NLM:


Further study details as provided by Lisa Yee, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • CU
  • Diferuloylmethane
  • NEC
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 Names:
  • Correlative studies
  • Breast adipose tissue
  • plasma samples
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 Name: questionnaires
Other: Daily Log
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.
Dietary Supplement: curcumin
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • CU
  • Diferuloylmethane
  • NEC
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 Names:
  • Correlative studies
  • Breast adipose tissue
  • plasma samples
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 Name: questionnaires
Other: Daily Log
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975363


Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Lisa Yee, MD 614-293-6654 Lisa.Yee@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Lisa D. Yee    614-293-6654    Lisa.yee@osumc.edu   
Principal Investigator: Lisa D. Yee, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Lisa Yee, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Lisa Yee, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01975363     History of Changes
Other Study ID Numbers: OSU-13034
NCI-2013-01199 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 20, 2013
First Posted: November 4, 2013
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lisa Yee, Ohio State University Comprehensive Cancer Center:
Breast Cancer

Additional relevant MeSH terms:
Curcumin
Carcinoma
Breast Neoplasms
Hyperplasia
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action