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

Primary Purpose

Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

curcumin

Biomarker analysis

Assessment of Dietary Intake

Daily Log

About this trial

This is an interventional prevention trial for Atypical Ductal Breast Hyperplasia focused on measuring Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I (lower dose curcumin)

Arm II (higher dose curcumin)

Arm Description

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 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.

Outcomes

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.

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.

Full Information

NCT ID

NCT01975363

First Posted

August 20, 2013

Last Updated

August 29, 2019

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01975363

Brief Title

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

Official Title

Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

September 19, 2016 (Actual)

Study Completion Date

September 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (lower dose curcumin)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (higher dose curcumin)

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

curcumin

Other Intervention Name(s)

C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane, NEC

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Biomarker analysis

Other Intervention Name(s)

Correlative studies, Breast adipose tissue, plasma samples

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Assessment of Dietary Intake

Other Intervention Name(s)

questionnaires

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Daily Log

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Clinton, MD

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://cancer.osu.edu

Description

Jamesline

Learn more about this trial

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

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