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

NCT01975363 | Completed DMC

• 2 other identifiers: OSU-13034NCI-2013-01199
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atypical Ductal Breast Hyperplasia; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Arm I (lower dose curcumin)

EXPERIMENTAL

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; Other: Biomarker analysis; Other: Assessment of Dietary Intake; Other: Daily Log

Arm II (higher dose curcumin)

EXPERIMENTAL

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; Other: Biomarker analysis; Other: Assessment of Dietary Intake; Other: Daily Log

Interventions

curcumin DIETARY_SUPPLEMENT

Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.

Also known as: C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane, NEC

Arm I (lower dose curcumin); Arm II (higher dose curcumin)

Biomarker analysis OTHER

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.

Also known as: Correlative studies, Breast adipose tissue, plasma samples

Arm I (lower dose curcumin); Arm II (higher dose curcumin)

Assessment of Dietary Intake OTHER

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.

Also known as: questionnaires

Arm I (lower dose curcumin); Arm II (higher dose curcumin)

Daily Log OTHER

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

Arm I (lower dose curcumin); Arm II (higher dose curcumin)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Curcumin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Steven Clinton, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: November 4, 2013
• Study Start: June 1, 2013
• Primary Completion: September 19, 2016
• Study Completion: September 19, 2016
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)