Omega 3 Fatty Acids for Breast Cancer Prevention

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how omega-3 fatty acids might prevent breast cancer recurrence in women who have already experienced the disease. Researchers aim to determine how different doses of these fatty acids affect specific cells and tissues in the breast. Participants will be divided into two groups to receive either a high or low dose of omega-3s through daily capsules. Women who have had a specific type of breast cancer and have completed their main treatments, such as surgery or chemotherapy, might be suitable for this study. As an unphased trial, this study offers the opportunity to contribute to important research that could benefit future breast cancer patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that omega-3 fatty acids are generally safe for consumption. These nutrients are often found in fish like salmon and tuna, which many people eat regularly. Studies have shown that most people tolerate omega-3s well. If side effects occur, they are usually mild, such as digestive issues like nausea or a slight fishy aftertaste. These effects are often temporary and not serious.

Many people already use omega-3 supplements for heart health and other benefits, suggesting their safety. While these studies did not specifically focus on cancer prevention, they provide some reassurance about safety. Overall, omega-3 fatty acids appear to be a safe choice for most people when taken as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional breast cancer prevention methods, which often involve hormonal therapies or lifestyle changes, omega-3 fatty acids offer a unique approach by potentially reducing cancer risk through dietary supplementation. Researchers are excited about omega-3s because they are thought to help prevent cancer by reducing inflammation and slowing the growth of cancer cells. This trial is looking into both high-dose and low-dose omega-3 regimens, making it a natural, accessible supplement option with promising potential for breast cancer prevention.

What evidence suggests that omega 3 fatty acids might be an effective treatment for breast cancer prevention?

This trial will compare the effects of high-dose versus low-dose omega-3 fatty acids on breast cancer prevention. Research has shown that omega-3 fatty acids can enhance both physical and mental health and may help reduce inflammation in breast cancer patients. Some studies suggest a link between omega-3 consumption and a lower risk of developing breast cancer. Specifically, three out of fourteen large reviews found a significant decrease in breast cancer risk with omega-3 intake. Additionally, omega-3s have been associated with changes in tissue markers that indicate breast cancer risk. This suggests that omega-3 fatty acids might help prevent breast cancer or support recovery. ^{1 4 5 6 7}

Who Is on the Research Team?

Lisa D Yee, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10420771/

The effectiveness of omega‐3 fatty acids on health outcomes ... Omega‐3 fatty acids may cause improvement in physical, mental, and some inflammatory and metabolic indices during treatment or posttreatment course of breast ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4418048/

Omega-3 fatty acids for breast cancer prevention and ... We will briefly review relevant omega-3 fatty acid metabolism, and early investigations in breast cancer prevention and survivorship.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/fsn3.3409

The effectiveness of omega‐3 fatty acids on health ... Omega-3 fatty acids may cause improvement in physical, mental, and some inflammatory and metabolic indices during treatment or posttreatment course of breast ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000461

Consumption of Fish and ω-3 Fatty Acids and Cancer Risk Among 14 meta-analyses, 3 showed a statistically significant result for reduction of breast cancer risk with ω-3 fatty acid intake. The remaining meta-analyses ...

5. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/8/5/359/50426/Omega-3-and-Omega-6-Fatty-Acids-in-Blood-and

Omega-3 and Omega-6 Fatty Acids in Blood and Breast ... This is the first report of associations between tissue levels of omega-3 and omega-6 fatty acids and a reversible tissue biomarker of breast cancer risk.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Cold-water fatty fish, such as salmon, mackerel, tuna, herring, and sardines, contain high amounts of LC omega-3s, whereas fish with a lower fat content—such as ...

7. esmoopen.com esmoopen.com/article/S2059-7029(25)00883-X/fulltext

442P The impact of omega-3 fatty acids on health ... This review aims to evaluate the effects of omega-3 fatty acids in women diagnosed with breast cancer patients, survivors, and high-risk individuals.