Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Lovaza-Omega 3 fatty acid capsules; Other: Dietary fish (canned salmon, albacore)

• Registration Number: NCT01282580
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2012-12
• Study Completion: 2014-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovaza-Omega 3 fatty acid capsules	Lovaza-Omega 3 fatty acid capsules	Lovaza capsules will be provided at no cost to the patient. Pill bottles will be provided to the patient, with the start date and number of pills recorded. The supplement will be provided in sufficient supply for one month at a time. Pill bottles will be collected at monthly follow-up visits, and any unused capsules will be documented and discarded as biohazardous waste.
Dietary fish (canned salmon, albacore)	Dietary fish (canned salmon, albacore)	Fish products: Canned albacore and salmon will be provided at no cost to the patient. Supplies of tuna and salmon will be provided in quantities sufficient for one month of daily intake by the subject. If desired, a subject can request a sufficient amount to allow for preparation of a meal for the family or household at no more than two times per week. Labels or portions of labels from the cans will be collected at the monthly study visits, and canned supplies will be replenished monthly or at more frequent intervals if needed. Subjects will be allowed to keep unused cans.

Primary Outcome Measures

Name	Time	Method
Fatty acid profiles of breast adipose tissue	0 and 3 months

Secondary Outcome Measures

Name	Time	Method
Fatty acid profiles of serum, red blood cell membranes	0 and 3 months

Trial Locations

Locations (1)

The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States