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Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention

NCT01282580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-30

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lovaza-Omega 3 fatty acid capsules

The study will require monthly visits at 0, 1, 2 and 3 months of study intervention. At each visit a fasting serum sample will be obtained, self-report diaries (adverse events, record of omega 3 supplement doses or fish servings taken/missed) will be collected, and pill count / labels from cans of fish will be recorded. Medications and supplements will be reviewed with participants at each monthly visit. At clinic visits at 0 and 3 months, a history and physical examination and breast adipose fine needle aspiration (FNA)will be performed.Omega 3 supplements will be dispensed in monthly amounts.

OTHER

Dietary fish (canned salmon, albacore)

Participants randomized to dietary fish will be asked to incorporate fish in the form of canned albacore and salmon into their diets at four 6 oz servings per week for 3 months. Participants on the dietary fish arm of the study will receive recipes using canned salmon and/or albacore. Sufficient canned salmon/albacore will be available for subjects who wish to prepare a meal for the family/household. Dietary intake will be assessed via 3 day diet records (0 and 3 months) and food frequency questionnaires (0 and 3 months). Verbal and written instructions on how to keep diet records, with food measured or weighed, will be given.

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lisa D Yee, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-12-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282580 on ClinicalTrials.gov