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Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue

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ClinicalTrials.gov Identifier: NCT01784042
Recruitment Status : Withdrawn (No funding)
First Posted : February 5, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Andrea Manni, Milton S. Hershey Medical Center

Brief Summary:
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Placebo Drug: Lovaza Other: Dietary energy restriction Early Phase 1

Detailed Description:
Obesity over the pre- and postmenopausal years is linked to the risk of postmenopausal breast cancer. Multiple mechanisms are likely to contribute to obesity associated breast cancer risk. They include increased insulin like growth factor (IGF)-I bioavailability, oxidative stress, raised leptin to adiponectin ratio, and increased inflammatory cytokines which are responsible for the creation of a systemic and local hyperestrogenic milieu by induction of aromatase and may also be responsible for the reduction in antitumor immunity by stimulation of immunosuppressive cells. While derivative chromosome disulfiram (DER) has been shown to reverse some of these obesity related phenotypic features, it is not yet established whether DER reduces breast cancer risk using validated tissue biomarkers predictive of breast cancer development. N:3FA (3-fatty acids) have been shown to ameliorate obesity-induced effects on circulating leptin and adiponectin, insulin resistance, endogenous estrogen production and inflammation. Although preclinical studies have indicated a protective effect of n:3FA on mammary carcinogenesis, the data in humans are inconclusive, likely as a result of the lack of controlled clinical trials. Investigators hypothesize that the combination of DER and n:3FA will reduce breast cancer risk in an additive/synergistic fashion through their complementary effects on the multiple inter-related pathways accounting for the obesity associated breast cancer risk. Investigators propose to conduct a clinical trial study involving overweight and obese women between the ages of 30 and 55 who are at high risk of breast cancer and are found on random periareolar fine needle aspiration to have hyperplasia with or without atypia with Ki67 ≥2 if premenopausal and ≥1.5 if postmenopausal. Following stratification according to menopausal status they will be randomized to one of four experimental groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk
Study Start Date : March 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: No dietary energy restriction plus Placebo
No dietary energy restriction plus Placebo
Drug: Placebo
placebo

Placebo Comparator: Dietary energy restriction plus placebo
Dietary energy restriction plus placebo
Drug: Placebo
placebo

Other: Dietary energy restriction
Experimental: Lovaza
Lovaza only
Drug: Lovaza
Other Name: Lovaza (omega-3-acid ethyl esters)

Experimental: Dietary energy restriction plus Lovaza
Dietary energy restriction plus Lovaza
Drug: Lovaza
Other Name: Lovaza (omega-3-acid ethyl esters)

Other: Dietary energy restriction



Primary Outcome Measures :
  1. Ki67 expression [ Time Frame: about 1 year ]
    Ki67 expression by hyperplastic breast lesions



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Five year predicted breast cancer risk of at least 1.66%.
  • Prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (DCIS).
  • Known breast cancer-1 and -2 mutations.
  • Breast density >50% as assessed by the conventional two-dimensional method.

Exclusion Criteria:

  • Weight loss of 10 pounds in past six months.
  • History of fish allergy.
  • Oral contraceptives or hormone replacement therapy in the past 6 months.
  • Pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months.
  • Current smoking.
  • Diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or DCIS.
  • Diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment.
  • Recent stroke or cardiovascular event.
  • History of eating disorders documented in medical records.
  • History of major gastrointestinal disease impairing absorption.
  • History of bariatric surgery.
  • Recent, current or planned use of diet drugs as per patient history.
  • Participants must not use flaxseed oil supplements during study participation.
  • Participants must not use Omega-3 preparations while participating on this trial.
  • Participants must not use Tamoxifen or Raloxifene during study participation.

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): NCT01784042


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Andrea Manni, MD Milton S. Hershey Medical Center

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Responsible Party: Andrea Manni, Professor and Chief, Division of Endocrinology, Diabetes and Metabolism, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01784042     History of Changes
Other Study ID Numbers: PSHCI 12-075
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Andrea Manni, Milton S. Hershey Medical Center:
breast cancer
omega-3 fatty acids
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases