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Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01282580
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE January 21, 2011
First Posted Date  ICMJE January 25, 2011
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2011)
Fatty acid profiles of breast adipose tissue [ Time Frame: 0 and 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01282580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2011)
Fatty acid profiles of serum, red blood cell membranes [ Time Frame: 0 and 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention
Official Title  ICMJE Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
    Other Name: canned fish
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Dietary fish (canned salmon, albacore)
  • Experimental: 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.
    Intervention: Dietary Supplement: Lovaza-Omega 3 fatty acid capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2011)
30
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01282580
Other Study ID Numbers  ICMJE OSU-10024
NCI-2012-02933 ( Registry Identifier: Clinical Trials Reporting Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Clinton, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa D Yee, MD Ohio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP