Olive Oil for Breast Cancer Prevention in Women at High Risk for Breast Cancer (Olive Oil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02068092
Recruitment Status : Recruiting
First Posted : February 21, 2014
Last Update Posted : October 2, 2017
The Methodist Hospital System
Information provided by (Responsible Party):
Tejal Patel, MD, The Methodist Hospital System

Brief Summary:
This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil, on mammographic density in women at high risk of breast through assessing whether mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol for 1 year compared with baseline imaging.

Condition or disease Intervention/treatment Phase
Family History of Breast Cancer Elevated Risk of Developing Breast Cancer Drug: Hydroxytyrosol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer
Study Start Date : December 2013
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: Hydroxytyrosol
Hydroxytyrosol 25mg oral daily
Drug: Hydroxytyrosol

Primary Outcome Measures :
  1. mammographic density [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. toxicity of hydroxytyrosol [ Time Frame: 3 years ]

Other Outcome Measures:
  1. assess proliferation as measured by Ki67 staining of breast epithelial cells [ Time Frame: 3 years ]
  2. explore the difference in the expression of other biomarkers [ Time Frame: 3 years ]
  3. Assess breast MRI density [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
  1. Participants must have ≥18 years of age.
  2. Participants must have an elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:

    1. Diagnosis of LCIS, atypical ductal or lobular hyperplasia.
    2. A known deleterious mutation in BRCA1, BRCA2, PTEN or TP53. (Note: The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per NCCN clinical guidelines to be eligible per this criterion.)
    3. Modified Gail/CARE model risk at 5 years ≥ 1.67%. (Note: Risk models are to be used only if there is no known previous diagnosis of resected DCIS or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN or TP53).
    4. 10% or more probability of BRCA mutation by BRCAPRO or similar model
    5. Cannot have DCIS or previous invasive ductal carcinoma
  3. Participants must have at least one breast available for imaging and biopsy. A previously irradiated breast (i.e., for resected DCIS) is not evaluable for breast imaging or biopsy.

    a. Participants must allow submission of core needle breast material (obtained per Section 7.3) for future use.

  4. Participants must have a baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that shows either normal or benign findings. Participants with mammograms that are reported as suspicious for malignancy are ineligible.
  5. Participants must have baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, "heterogeneously dense"; 4 = >75%, "extremely dense"). Women with a baseline mammographic density of ≤ 10% (1 = ≤10%, breasts are almost entirely fat) will not be eligible
  6. Prior tamoxifen or raloxifene use is allowed provided treatment is completed at least 1 year prior to registration
  7. Participants must not have bilateral breast implants, but prior breast reduction surgery is allowed. (Breast implants are not allowed as they affect density measurements and because of the risk of rupturing the implant with biopsy).
  8. Participants must have a ECOG Performance Status of 0 - 1 (see Section 11).
  9. Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For subjects who have taken an anticoagulation within the past 7 days, INR (International Normalized Ratio) must be ≤ 1.5 x institutional upper limit of normal and Prothrombin Time and Partial Thromboplastin Time ≤ IULN prior to the breast biopsy.
  10. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
  11. Participant must not be pregnant or nursing and must agree to use effective contraception. Hormone-based birth control (pills, patches or shots) are allowed, but switching birth control methods is discouraged while on-study as hormonal changes can affect mammographic density. Hormone replacement therapy is not allowed for post-menopausal female.
  12. Individuals must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. Participants must also agree not to join such a trial while participating in this study.
  13. All participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  14. Exclude patients with prior Tamoxifen and Raloxifene use in the past year Exclusion Criteria

1. Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.

2. Prior Tamoxifen or Raloxifene use in the past 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02068092

Contact: Houston Methodist Cancer Center 713-441-0629

United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Houston Methodist Cancer Center    713-441-0629   
Sub-Investigator: Jenny CN Chang, MD         
Sub-Investigator: Angel A Rodriguez, MD         
Sub-Investigator: Daniel Lehane, MD         
Sub-Investigator: Monisha Singh, MD         
Sub-Investigator: Jorge Darcourt, MD         
Houston Methodist Hospital Willowbrook Recruiting
Houston, Texas, United States, 77070
Contact: Houston Methodist Cancer Center    713-441-0629   
Principal Investigator: Anna Belcheva, MD         
Houston Methodist Hospital Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
Contact: Houston Methodist Cancer Center    713-441-0629   
Principal Investigator: Jorge Darcourt, MD         
Sponsors and Collaborators
Tejal Patel, MD
The Methodist Hospital System
Principal Investigator: Tejal Patel, MD The Methodist Hospital System

Additional Information:
Responsible Party: Tejal Patel, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System Identifier: NCT02068092     History of Changes
Other Study ID Numbers: Pro00009472
0713-0108 ( Other Identifier: HMRI IRB )
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Phenylethyl Alcohol
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anti-Infective Agents, Local