Clinical trial NCT01282580: Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention
Official title: Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Women at high risk of developing breast cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research studies show that the type of fat in the diet may affect breast cancer risk. Fish oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow down the growth and development of breast cancer cells in laboratory studies of mice and breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer development in humans has not been adequately studied. Eating fish or taking fish oil may increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer development.

Persons in this study with do one of the following: (1) take two capsules daily of omega 3 fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.

This study is supported by funding from the National Fisheries Institute, Food Innovation Center of The Ohio State University, and The Ohio State University Comprehensive Cancer Center.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatty acid profiles of breast adipose tissue
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Fatty acid profiles of serum, red blood cell membranes
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lisa D Yee, MD
role: PRINCIPAL_INVESTIGATOR
References: