Breast CancerPhase 1NCT01282580
Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention
A Phase 1 study testing Lovaza-Omega 3 fatty acid capsules and Dietary fish (canned salmon, albacore) in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lovaza-Omega 3 fatty acid capsules and Dietary fish (canned salmon, albacore)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Lovaza-Omega 3 fatty acid capsules, Dietary fish (canned salmon, albacore)
- Keywords
- Women at high risk of developing breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza-Omega 3 fatty acid capsulesDietary supplement
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.
Dietary fish (canned salmon, albacore)Other
Also called canned fish
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary fish (canned salmon, albacore) | Experimental | 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. Receives: Other: Dietary fish (canned salmon, albacore) |
| Lovaza-Omega 3 fatty acid capsules | Experimental | 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. Receives: Dietary Supplement: Lovaza-Omega 3 fatty acid capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid profiles of breast adipose tissue
Measured: 0 and 3 months
Secondary outcomes (1)
Fatty acid profiles of serum, red blood cell membranes
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Lisa D Yee, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282580
- Sponsor's protocol ID
- OSU-10024
- Other IDs
- NCI-2012-02933
- Status last verified
- Aug 2019
- First submitted
- 21 Jan 2011
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega 3 Fatty Acids and Breast Cancer Prevention: Protective Benefits of Increased Fish Consumption
- ClinicalTrials.gov ID
- NCT01282580
- Acronym / sponsor ID
- OSU-10024
- Conditions
- Breast Cancer
- Keywords
- Women at high risk of developing breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary fish (canned salmon, albacore) | Experimental | Other: 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. |
| Lovaza-Omega 3 fatty acid capsules | Experimental | Dietary Supplement: Lovaza-Omega 3 fatty acid capsulesLovaza 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza-Omega 3 fatty acid capsulesThe 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. | Dietary supplement | Lovaza-Omega 3 fatty acid capsules |
| Dietary fish (canned salmon, albacore)Also: canned fishParticipants 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 | Dietary fish (canned salmon, albacore) |
Primary outcome
Fatty acid profiles of breast adipose tissue
Time frame: 0 and 3 months
1 secondary outcome
Fatty acid profiles of serum, red blood cell membranes
Time frame: 0 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa D Yee, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lovaza-Omega 3 fatty acid capsules and Dietary fish (canned salmon, albacore) in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acid profiles of breast adipose tissue (time frame: 0 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.