Omega-3 Fish Oil for Breast Cancer

(CLARA Trial)

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical College of Wisconsin
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential effects of omega-3 fish oil supplements on breast cancer treatment. Researchers aim to determine if these supplements alter the fats in breast tissue and enhance the response to treatment before surgery. Participants must have a breast tumor larger than 1 cm and should not currently use fish oil supplements. The study permits standard cancer treatments, such as chemotherapy or hormone therapy, alongside the fish oil supplement. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that omega-3 fish oil is likely to be safe for humans?

Research has shown that omega-3 fish oil supplements are generally safe for most people, with up to 3 grams a day usually well-tolerated. Studies have not identified major safety concerns, even when combined with cancer treatments like chemotherapy. Some research suggests that omega-3s might help reduce inflammation and slow cancer cell growth.

While fish oil may boost overall health, its effects on breast cancer remain under study. Current research links fish oil supplements to a lower risk of some breast cancer types, but benefits can vary based on personal health factors like weight.

Overall, fish oil supplements are considered safe, but consulting a healthcare provider before using any supplements, especially when dealing with cancer, is always wise.12345

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard breast cancer treatments like chemotherapy, radiation, and hormone therapy, the Mini rTG OMEGA-3 Fish Oil is a dietary supplement derived from omega-3 fatty acids. Researchers are excited about this treatment because omega-3s have anti-inflammatory properties, which might help reduce tumor growth and spread. Additionally, being a natural supplement, it could potentially offer a less invasive and more tolerable option for patients compared to traditional treatments.

What evidence suggests that omega-3 fish oil might be an effective treatment for breast cancer?

This trial will evaluate the effects of Mini rTG OMEGA-3 Fish Oil, a commercially available dietary supplement, on breast cancer. Studies have shown that omega-3 fatty acids in fish oil may improve outcomes for breast cancer patients. Research suggests these fatty acids can slow cancer cell growth and reduce inflammation, a common factor in cancer progression. One study found that regularly taking fish oil supplements linked to a 32% lower risk of breast cancer. In animal studies, omega-3s led to a 60-70% reduction in tumor size. Additionally, fish oil might enhance chemotherapy effectiveness and help protect against some of its side effects.26789

Who Is on the Research Team?

LC

Lubna Chaudhary, MD, MS

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for people with early-stage breast cancer who are scheduled to have surgery. Participants can continue their usual cancer treatments, like chemotherapy or hormone therapy, while taking the study supplement.

Inclusion Criteria

I am 18 years old or older.
My breast tumor is at least 1 cm in size.
I am not taking fish oil or omega-3 supplements.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omega-3 PUFA supplementation for 4 to 28 weeks prior to surgical resection of breast tumor(s)

4 to 28 weeks

Surgical Resection

Surgical resection of breast tumor(s) is performed

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mini rTG OMEGA-3 Fish Oil

Trial Overview

The study tests if taking a special omega-3 fish oil supplement before breast cancer surgery changes fat composition in tumor tissue and affects response to treatment. All participants receive the supplement along with any standard therapies.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dietary InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Citations

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 ...

Fish-derived omega-3 best for preventing breast cancer

The team found that mice exposed to the fish oil-derived omega-3s EPA and DHA experienced a 60–70 percent reduction in tumor size, as well as a ...

Dietary Fish and Omega 3 Fatty Acids for Breast Cancer ...

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 ...

Fish Oil and Cancer

Fish oil supplementation may improve chemotherapy-related outcomes, such as time to tumor progression, and may be protective against certain toxicities.

Fish oil may reduce breast cancer risk - Fred Hutch

Regular use of fish oil supplements, which contain high levels of the omega-3 fatty acids EPA and DHA, is associated with a 32 percent reduction in breast ...

Omega-3 fatty acids for the prevention of breast cancer - PMC

Current, but not past, use of fish oil supplements was associated with a decreased risk of developing invasive ductal carcinomas within the breast. 14. Kim ...

Fish Oil

When taken by mouth: Fish oil is likely safe for most people in doses of 3 grams or less daily. ... Pregnancy and breast-feeding: Fish oil supplements are likely ...

Foods Containing Omega-3 Fatty Acids

But research so far on whether omega-3 fatty acids affect breast cancer risk has shown no conclusive association. ... Many fish with high levels ...

Fish oil supplements may not work for certain cancer patients

Personalized dosing of omega-3 fatty acids decreases prostaglandin E2 in the colon, but the beneficial effects are smaller in overweight people, ...