This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer.
This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer. Participants will take hydroxytyrosol orally once daily for 1 year. Breast density as determined by mammography and the safety/toxicity of hydroxytyrosol will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
51
Houston Methodist Hospital
Houston, Texas, United States
Houston Methodist Hospital Willowbrook
Houston, Texas, United States
Houston Methodist Hospital Sugar Land
Sugar Land, Texas, United States
Change in Maximum Volumetric Breast Density Percentage
Change in Maximum Volumetric Breast Density Percentage from Baseline at 12 Months. Maximum volumetric breast density (max VBD%) which is calculated by fibroglandular breast volume divided by total breast volume (checked on the higher side, left or right) was used to obtain the study's endpoints. The primary endpoint was the annualized percent decrease in max VBD% between baseline (BL) and end-of-treatment (EOT) with HT.
Time frame: Baseline and 12 months
Number of Participants With Adverse Events
Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03
Time frame: From informed consent up to 12 months
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