Omega 3 Fatty Acids for Breast Cancer Prevention

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: Anticoagulants, Omega 3, NSAIDs, others

Disqualifiers: Current malignancy, Breast implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking anticoagulants like Coumadin, full dose aspirin, NSAIDs, or omega 3 supplements. If you are on these, you would need to stop them before joining the trial.

What data supports the effectiveness of the treatment Omega 3 Fatty Acids for breast cancer prevention?

Research suggests that omega-3 fatty acids, found in fish oils, may help reduce the risk of breast cancer by inhibiting cancer cell growth and reducing tumor progression. Additionally, higher intake of these fatty acids from food sources is linked to a lower risk of breast cancer recurrence and improved survival rates. ^{1 2 3 4 5}

Is it safe for humans to take omega-3 fatty acids?

Omega-3 fatty acids, commonly found in fish oils, are generally considered safe for human consumption and have been studied for their potential protective effects against various cancers, including breast cancer. ^{1 3 6 7 8}

How does the treatment Omega 3 Fatty Acids differ from other treatments for breast cancer prevention?

Omega 3 Fatty Acids are unique in breast cancer prevention because they may reduce cancer risk by altering the balance of fatty acids in the body, specifically increasing beneficial omega-3s like EPA and DHA while reducing omega-6s. This can lead to decreased inflammation and changes in cell signaling that may help prevent cancer, which is different from traditional treatments that often target cancer cells directly. ^{1 3 6 7 9}

What is the purpose of this trial?

The study aims to determine biological changes associated with a low vs high dose of omega 3 fatty acids, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), over 12 months in women at risk for recurrent breast cancer. The objectives of the trial are to develop mammary epithelial, adipose tissue specific markers of exposure and response to omega 3 fatty acid supplements that can be carried forward into definitive intervention trials of omega 3 fatty acids for breast cancer prevention. The investigators will randomize 80 subjects with hormone receptor negative, HER-2/neu overexpression positive or negative breast cancer to either a high or low dose of omega 3 fatty acids. Using fine needle aspiration to procure cellular samples of breast epithelial and adipose tissue, the investigators will determine the effects of omega 3 fatty acids on mammary specific biomarkers of response.

Research Team

Lisa D Yee, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women who've had Stage 0 to III breast cancer that's hormone receptor negative and HER-2/neu positive or negative. They should be done with major treatments like chemotherapy for at least six months, not currently pregnant or nursing, and without other cancers or serious illnesses that could interfere with the study.

Inclusion Criteria

You have not been pregnant or breastfeeding for at least one year.

You finished chemotherapy or trastuzumab treatment more than six months ago, or radiation therapy more than two months ago, and it has been five years or less since you finished your standard treatment.

You had early-stage breast cancer that was estrogen receptor negative and progesterone receptor negative, and you finished treatment like surgery, radiation, or chemotherapy.

Exclusion Criteria

You have breast implants.

Pregnant or nursing women

You are currently getting treatment for cancer like chemotherapy or radiation therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high or low dose of omega 3 fatty acids for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Omega 3 Fatty Acids

Trial Overview The study tests how different doses of omega 3 fatty acids (DHA and EPA) affect biological markers in breast tissue over a year. Women will be randomly assigned to either a high or low dose group, and researchers will use fine needle aspiration to collect cell samples from their breasts.

Participant Groups

Group I: Omega 3 fatty acids - low dose Experimental Treatment 1 Intervention

\~0.9 g EPA+DHA + fatty acids based on the typical American diet in 5 capsules per day

Group II: Omega 3 fatty acids - high dose Experimental Treatment 1 Intervention

\~5 g EPA+DHA in 5 capsules per day

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Long-chain omega-3 fatty acids, found in high levels in certain fish oils, may help protect against common cancers like breast and colon cancer, based on both epidemiological and experimental evidence.

These protective effects are thought to work through various mechanisms, including inhibiting cancer cell growth and promoting cell death, primarily by reducing the production of harmful eicosanoids from omega-6 fatty acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids as cancer chemopreventive agents. Rose, DP., Connolly, JM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acid supplements in women at high risk of breast cancer have dose-dependent effects on breast adipose tissue fatty acid composition. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Marine fatty acid intake is associated with breast cancer prognosis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids as cancer chemopreventive agents. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Dietary Fat, Fatty Acids and Breast Cancer. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Oral Docosahexaenoic Acid (DHA) Supplementation on DHA Levels and Omega-3 Index in Red Blood Cell Membranes of Breast Cancer Patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of omega-3 polyunsaturated Fatty Acid consumption on mammary carcinogenesis. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Fatty fish and fish omega-3 fatty acid intakes decrease the breast cancer risk: a case-control study. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

The inhibition of early stages of HER-2/neu-mediated mammary carcinogenesis by dietary n-3 PUFAs. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids for breast cancer prevention and survivorship. [2018]