Clinical trial · Interventional
Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer
NCT00114296CI-TRIAL-00012148unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Breast density as measured by the Madena method at 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 treatmentReferences
Publications (0)
Data not yet available
No reference posted for this study.