Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01975363
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date September 19, 2016

See also
  Status Clinical Trial Phase
Completed NCT02314156 - Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy Phase 2
Completed NCT01874184 - Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer N/A
Active, not recruiting NCT01905046 - Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer Phase 3
Completed NCT01869764 - Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer Phase 2
Completed NCT02587663 - Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI N/A
Active, not recruiting NCT04537312 - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) N/A
Active, not recruiting NCT01245712 - Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer Phase 2
Recruiting NCT02993159 - Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast Phase 2
Completed NCT01753908 - Broccoli Sprout Extract in Treating Patients With Breast Cancer Early Phase 1
Terminated NCT02023008 - Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy N/A
Terminated NCT01754519 - Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery Phase 2
Completed NCT01849250 - Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors Phase 2
Completed NCT01819233 - Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy N/A
Active, not recruiting NCT03077841 - Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer Phase 2/Phase 3
Active, not recruiting NCT02352883 - MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ N/A
Recruiting NCT03909282 - Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma N/A
Completed NCT01723943 - Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients N/A
Completed NCT00637481 - A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer Phase 1
Active, not recruiting NCT03391388 - 3D-CRT, Proton, or Brachytherapy APBI in Treating Patients With Invasive and Non-invasive Breast Cancer Phase 2
Completed NCT02526498 - Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery Phase 2