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Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption


The primary objectives of this study are to:

i.) Determine the effects of increased fish consumption on serum and breast fat tissue fatty
acids in women at high risk for developing breast cancer relative to an omega 3 fatty acid
supplement;

ii.) Assess adherence and tolerability of increased dietary intake of fish relative to an
omega 3 fatty acid supplement.

Secondary objectives include:

iii.) Evaluate possible correlations between physical factors such as body mass index (BMI)
and dietary factors and target tissue effects.

iv.) Explore additional biomarkers as surrogate endpoints to measure effects of fish
consumption.


Inclusion Criteria:



- Increased risk for breast cancer based on family history, personal history

- Normal mammogram, clinical breast examination in the past 12 months

- >1 year from pregnancy, lactation or chemotherapy

Exclusion Criteria:

- Concurrent malignancy or metastatic malignancy of any kind

- History of a bleeding tendency, use of anticoagulant medications

- Inability to undergo fine needle aspiration of breast adipose tissue

- Chronic use of omega-3 fatty acid supplements or regular consumption of > 2
meals/servings of fish per week within the 3 months prior to entry on the study or
any other supplements that might interact with omega-3 fatty acid supplements

- Known sensitivity or allergy to fish

- Standing regimen of full dose aspirin (325 mg/day or more), Non-steroidal
anti-inflammatory drugs (NSAIDs) or NSAID-containing products.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Fatty acid profiles of breast adipose tissue

Outcome Time Frame:

0 and 3 months

Safety Issue:

No

Principal Investigator

Lisa D Yee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-10024

NCT ID:

NCT01282580

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Women at high risk of developing breast cancer
  • Breast Neoplasms

Name

Location
The Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210