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

NCT01975363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-08-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

curcumin

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

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

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

Daily Log

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

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Steven Clinton, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-09-19
Completion
2016-09-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975363 on ClinicalTrials.gov