A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 51
- Locations
- 3
- Primary Endpoint
- Change in Maximum Volumetric Breast Density Percentage
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Hydroxytyrosol
Hydroxytyrosol 25 mg orally once daily for 1 year.
Intervention: Hydroxytyrosol (Drug)
Outcomes
Primary Outcomes
Change in Maximum Volumetric Breast Density Percentage
Time Frame: Baseline and 12 months
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.
Secondary Outcomes
- Number of Participants With Adverse Events(From informed consent up to 12 months)
Investigators
Jenny C. Chang, MD
Principal Investigator
The Methodist Hospital Research Institute