Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Olive Oil for High Risk Breast Cancer Prevention in Women

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.
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

Tracking Information
First Submitted Date  ICMJE February 18, 2014
First Posted Date  ICMJE February 21, 2014
Last Update Posted Date July 24, 2018
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Mammographic breast density [ Time Frame: 3 years ]
To determine breast density as assessed by mammography
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
mammographic density [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT02068092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
toxicity of hydroxytyrosol [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures
 (submitted: July 20, 2018)
  • Expression of Ki67 in tumor tissue [ Time Frame: 3 years ]
    To determine the expression of Ki67 in tumor tissue
  • MRI breast density [ Time Frame: 3 years ]
    To determine breast density as assessed by magnetic resonance imaging
Original Other Pre-specified Outcome Measures
 (submitted: February 18, 2014)
  • assess proliferation as measured by Ki67 staining of breast epithelial cells [ Time Frame: 3 years ]
  • explore the difference in the expression of other biomarkers [ Time Frame: 3 years ]
  • Assess breast MRI density [ Time Frame: 3 years ]
 
Descriptive Information
Brief Title  ICMJE Olive Oil for High Risk Breast Cancer Prevention in Women
Official Title  ICMJE A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Hydroxytyrosol
Study Arms  ICMJE Experimental: Hydroxytyrosol
Hydroxytyrosol 25 mg orally once daily for 1 year.
Intervention: Drug: Hydroxytyrosol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02068092
Other Study ID Numbers  ICMJE Pro00009472
0713-0108 ( Other Identifier: HMRI IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: To be determined
Responsible Party Tejal Patel, MD, The Methodist Hospital System
Study Sponsor  ICMJE Tejal Patel, MD
Collaborators  ICMJE The Methodist Hospital System
Investigators  ICMJE
Principal Investigator: Tejal Patel, MD The Methodist Hospital System
PRS Account The Methodist Hospital System
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP