Olive Oil for High Risk Breast Cancer Prevention in Women

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Hydroxytyrosol

• Registration Number: NCT02068092
• Lead Sponsor: The Methodist Hospital Research Institute

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-21
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Results First Submitted: 2023-01-13
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Results First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydroxytyrosol	Hydroxytyrosol	Hydroxytyrosol 25 mg orally once daily for 1 year.

Primary Outcome Measures

Name	Time	Method
Change in Maximum Volumetric Breast Density Percentage	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 Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From informed consent up to 12 months	Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03

Trial Locations

Locations (3)

Houston Methodist Hospital Willowbrook; 🇺🇸 Houston, Texas, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Houston Methodist Hospital Sugar Land; 🇺🇸 Sugar Land, Texas, United States