Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Curcumin in Reducing Inflammatory Changes in Breast Tissue in Obese Patients At High Risk for Breast Cancer

Protocol: OSU-13034

Full Title

Nanoemulsion curcumin for obesity, inflammation and breast cancer prevention a pilot trial

Purpose

This randomized pilot clinical trial compares whether a higher or lower dose of a new formulation of curcumin will reduce inflammatory changes in breast tissue in obese patients at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may lower the risk of developing breast cancer.

Study Objective

PRIMARY OBJECTIVES:

I. To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;

II. To determine whether NEC modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.

SECONDARY OBJECTIVES:

I. Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.

II. Explore additional biomarkers as surrogate endpoints to measure effects of NEC.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive 50 mg nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.

ARM II: Participants receive 100 mg nanoemulsion curcumin PO BID for 3 months.

Are you eligible?

Inclusion Criteria:

Subjects who are at high risk for breast cancer will be considered for participation in the study

The ethnic and racial composition of the subject population will reflect the composition of subjects seeking care at The Ohio State University and James Cancer Hospital and Solove Research Institute; no special groups such as prisoners, children, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question will be used for this study

Definition of a high risk population:

The study population will consist of women with a relative risk of developing breast cancer that is at least > 2 x that of the general population for their age group on the basis of any of the following:

  • Have a known genetic mutation associated with hereditary breast cancer (including breast cancer [BRCA]1, BRCA2, tumor protein [p]53, etc.)
  • One or more first degree relatives with breast cancer, with at least one under the age of 60
  • Two or more second degree relatives with breast cancer, with at least one under the age of 50
  • Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years
  • Have a Gail Risk Assessment (which is based on age, race, age of menarche, age of first live birth, number of first degree relatives with breast cancer, number of breast biopsies, and presence of high risk histology on any biopsies) that is considered high risk compared to the general population:

*** 5 year Gail >= 1.7 or

*** 10 year Gail >= 3.4%

  • Prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years, without chemotherapy or antiestrogen therapy for > six months and >= 2 months since completion of radiation therapy, when applicable

ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL

Body mass index (BMI) between 30 - 40

Must be > 1 year from pregnancy, lactation or chemotherapy

Must have had a mammogram within the 12 months prior to study enrollment; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered once they have had a negative biopsy

Must be willing to undergo fine needle aspiration of breast adipose tissue at 0 and 3 months of the study

Must be willing to have about 30 ml of blood (approximately 6 teaspoons) drawn at 0 and 3 months and about 5-10 ml of blood (approximately 1-2 teaspoons) at 1 and 2 months

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Written signed informed consent; patients must be aware of their diagnosis and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts

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 antacids, hydrogen (H2) antagonists, proton-pump inhibitors, or 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 as determined by clinical examination and/or mammogram

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

Pregnant or nursing women

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

Subjects who cannot give an informed consent

Breast Cancer