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Breast CancerNCT00114296

Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

A study testing omega-3 fatty acid in people with Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
omega-3 fatty acid
How many people
80 participants
Where
1 siteUnited States
Study dates
Apr 2005to not given
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • At increased risk of developing breast cancer, as defined by 1 of the following criteria:
  • 5-year Gail risk ≥ 1.7%
  • Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1 of the following:
  • At least 0.1% (for patients age 20-29)
  • At least 1.0% (for patients age 30-39)
  • At least 1.7% (for patients age 40 and over)
  • Known BRCA1 or BRCA2 mutation carrier
  • Family history consistent with hereditary breast cancer, as defined by any of the following:
  • At least 4 relatives diagnosed with breast cancer at any age
  • At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger
  • Breast and ovarian cancer diagnosed in the same relative
  • At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family
  • Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy
  • History of unilateral ductal carcinoma in situ of the breast
  • History of invasive stage I breast cancer in remission (completed local and systemic standard therapy)
  • History of ovarian cancer in remission for > 5 years
  • Baseline mammogram performed within the past 6 months with an interpretation of not suspicious for malignancy (BIRAD 1-3)
  • Not eligible for OR refused standard breast cancer risk reduction strategies (e.g., prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL

Hepatic

  • SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 2.0 times ULN

Renal

  • Creatinine ≤ 2.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No underlying medical, psychiatric, or social condition that would preclude study participation
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 6 months since prior and no concurrent hormonal therapy, including any of the following:
  • Antiestrogens
  • Estrogen
  • Selective estrogen-receptor modulators
  • Progestins
  • Aromatase inhibitors
  • Hormonal contraceptives

Radiotherapy

  • Not specified

Surgery

  • No prior bilateral mastectomy

Other

  • More than 3 months since prior and no concurrent chronic (i.e., > 3 times per week) non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or cyclooxygenase-2 inhibitors
  • No prior cancer treatment that would preclude study treatment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer

RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.

PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer.

Secondary

  • Determine, preliminarily, the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients.
  • Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients.
  • Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients.
  • Determine the effects of this supplement on plasma lipid peroxidation levels in these patients.
  • Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement.

OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral placebo three times daily for 12 months.
  • Arm II: Patients receive oral omega-3 fatty acids three times daily for 12 months.

In both arms, treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.

Conditions
Breast Cancer
Being tested
omega-3 fatty acid
Keywords
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.

  • omega-3 fatty acidDietary supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast density as measured by the Madena method at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2005 (estimated)
  2. Study startApr 2005

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114296
Sponsor's protocol ID
CDR0000430701
Other IDs
CSMC-00006359, CSMC-00000509
Status last verified
Jul 2006
First submitted
13 Jun 2005
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing omega-3 fatty acid in people with Breast Cancer, run by Cedars-Sinai Medical 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?

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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. 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.

Are results available for this study?

Results are not available in the source record.

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?

Breast density as measured by the Madena method at 1 year. 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 17 Sep 2013.

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