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Olive Oil for High Risk Breast Cancer Prevention in Women

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ClinicalTrials.gov Identifier: NCT02068092
Recruitment Status : Recruiting
First Posted : February 21, 2014
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
Tejal Patel, MD, The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Hydroxytyrosol Phase 2 Phase 3

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 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 25 mg orally once daily for 1 year.
Drug: Hydroxytyrosol



Primary Outcome Measures :
  1. Mammographic breast density [ Time Frame: 3 years ]
    To determine breast density as assessed by mammography


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 3 years ]
    Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03


Other Outcome Measures:
  1. Expression of Ki67 in tumor tissue [ Time Frame: 3 years ]
    To determine the expression of Ki67 in tumor tissue

  2. MRI breast density [ Time Frame: 3 years ]
    To determine breast density as assessed by magnetic resonance imaging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Female aged ≥18 years of age.
  2. 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 lobular carcinoma in situ (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 National Comprehensive Cancer Network 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 ductal carcinoma in situ [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
  3. 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. Allow for submission of core needle breast material for future use.

  4. Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
  5. 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. Eastern Cooperative Oncology Group performance status of 0-1.
  7. 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 participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ≤ 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ≤ ULN prior to the breast biopsy.
  8. Must agree to use effective consistent contraception. Hormone-based birth control (pills, patches, or shots) is allowed. Hormone replacement therapy is not allowed for postmenopausal participants.
  9. 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.
  10. Provide written informed consent.

Exclusion Criteria

  1. DCIS or previous invasive ductal carcinoma.
  2. Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
  3. Prior tamoxifen or raloxifene use in the past 1 year.
  4. Pregnant or breastfeeding.
  5. Bilateral breast implants. Prior breast reduction surgery is allowed.
  6. Mammograms that are reported as suspicious.

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 ClinicalTrials.gov identifier (NCT number): NCT02068092


Contacts
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Houston Methodist Cancer Center    713-441-0629    ccresearch@houstonmethodist.org   
Sub-Investigator: Jenny CN Chang, 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    ccresearch@houstonmethodist.org   
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    ccresearch@houstonmethodist.org   
Principal Investigator: Jorge Darcourt, MD         
Sponsors and Collaborators
Tejal Patel, MD
The Methodist Hospital System
Investigators
Principal Investigator: Tejal Patel, MD The Methodist Hospital System

Responsible Party: Tejal Patel, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov 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: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
3,4-dihydroxyphenylethanol
Phenylethyl Alcohol
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anti-Infective Agents, Local
Disinfectants