Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
Sponsor: Ohio State University Comprehensive Cancer Center
A NA clinical study on Atypical Ductal Breast Hyperplasia and BRCA1 Gene Mutation, this trial is completed. The trial is conducted by Ohio State University Comprehensive Cancer Center and has accumulated 8 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
-
Sep 2024 — Present [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2021 — Jul 2024 [monthly]
Completed NA
-
Sep 2019 — Jan 2021 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
▶ Show 3 earlier versions
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Jun 2018 — Sep 2019 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
-
Feb 2017 — Jun 2018 [monthly]
Recruiting NA
-
Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
Jun 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Ohio State University Comprehensive Cancer Center
For direct contact, visit the study record on ClinicalTrials.gov .