Active not recruitingPHASE2INTERVENTIONAL

Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting

This research is investigating if a natural fat called Docosahexaenoic Acid (DHA), found in fish oil, can improve treatment for women with breast cancer. Many women with breast cancer receive chemotherapy before surgery, and this study aims to see if adding DHA can make the chemotherapy more effective in shrinking the cancer cells. It also explores if DHA could help reduce some of the chemotherapy's unwanted side effects. Researchers will give women either DHA capsules or a dummy capsule (placebo) alongside their standard chemotherapy, monitoring changes in cancer cells and overall health. The goal is to find better ways to treat breast cancer and make the treatment journey easier.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

28 Aug 2019

Estimated completion

01 Sep 2030

Breast Cancer

What is this study about?

This study is looking into whether a specific type of omega-3 fat called Docosahexaenoic Acid, or DHA, can help women with early breast cancer. DHA is a natural substance found in things like oily fish and fish oil supplements. We know that DHA can affect how cells behave in the body, and some early research suggests it might make breast cancer cells more sensitive to chemotherapy drugs, potentially helping them shrink more effectively.

Doctors often use chemotherapy before surgery for breast cancer. This study wants to see if adding DHA to this treatment plan can improve how well the chemotherapy works to reduce the size of the cancer. A key part of this research will be to understand if DHA can also protect healthy cells from the harsh effects of chemotherapy, which might mean fewer side effects for patients. The researchers are particularly interested in whether DHA changes certain markers in the cancer cells that show how quickly they are growing, and how it affects the body's immune system.

The overall aim is to explore if combining DHA with standard chemotherapy can offer a double benefit: making the cancer treatment more effective while also making it more tolerable for patients. If successful, this could open up new ways to support women going through breast cancer treatment.

Key takeaways

The study explores if DHA (a type of omega-3 fat) can improve breast cancer chemotherapy.
DHA might make chemotherapy more effective and reduce its side effects.
Participants take DHA or dummy capsules alongside their usual chemotherapy treatment.
Impact on cancer cells and general well-being will be monitored.
This is an addition to standard treatment, not a replacement.
You can stop participating at any time.

Who may be eligible?

This study is for women who have breast cancer that has spread slightly but is still within the breast or nearby lymph nodes (stages I, II, or III), and for whom their doctor has recommended chemotherapy before surgery. You'll need to be generally well enough to go about your daily activities with little difficulty.

To be considered, your blood test results for your kidneys, liver, and blood counts should be within a healthy range, or any slight changes shouldn't be a concern for the medical team. You must also be able to take medicines by mouth, and there needs to be enough cancer tissue from your initial biopsy for the researchers to do their special tests.

However, you can't join if you've already had surgery for your breast cancer before chemotherapy, or if you regularly take high doses of omega-3 supplements or fish oil. If you have severe allergies to corn or soy, or certain other serious health conditions like a history of blood clots, heart problems, or a recent diagnosis of another type of cancer (unless it's a treated skin cancer), you won't be able to participate. Also, if you take high doses of certain antioxidant supplements like vitamin C or E, or have certain eye or mental health conditions, this study might not be right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman with breast cancer (stages I, II, or III) needing chemotherapy before surgery?
Are you generally well and able to manage daily activities?
Are your routine blood tests (for kidneys, liver, blood counts) mostly normal?
Can you comfortably take medicines by mouth?
Do you avoid regular high-dose omega-3 supplements or fish oil?
Do you NOT have severe allergies to corn or soy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive DHA capsules or dummy capsules (placebo) each day. You'll take 11 capsules daily, spreading them out throughout the day, for a total of about 12 to 18 weeks. This will start at the same time as your first course of chemotherapy and continue throughout your 4 to 6 cycles of chemo, which typically last three weeks each. You will stop taking the capsules about three weeks after your last chemotherapy treatment.

Throughout the study, you'll have regular hospital visits for your chemotherapy. During these visits, blood samples will be taken before each chemotherapy cycle to check your immune system and levels of fats in your blood. The research team will also look at samples from your breast cancer: one from your initial biopsy before treatment starts, and another from the tumour removed during surgery after your chemotherapy. These samples will help them understand how the treatment has affected the cancer cells.

Potential risks and benefits

Participating in this study might offer potential benefits, such as the possibility that DHA could make your chemotherapy more effective or reduce some of its side effects, though this is not guaranteed. However, there are also potential risks, including side effects from taking DHA (though it's generally well-tolerated) or from the standard chemotherapy itself. Being in the study means more blood tests and assessments than usual. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada

Common questions

What is DHA?

DHA stands for Docosahexaenoic Acid. It's a healthy fat found in things like oily fish and fish oil supplements, and it's a type of omega-3 fatty acid.

Why are doctors studying DHA for breast cancer?

Early research suggests DHA might help chemotherapy drugs work better against breast cancer cells and could also reduce some of the unpleasant side effects of chemotherapy.

Will I know if I'm getting DHA or a dummy capsule?

No, this is a 'blinded' study. To get reliable results, neither you nor your doctors will know if you're taking the DHA or a dummy capsule until the study is over.

How long will I take the capsules for?

You'll take the capsules daily alongside your chemotherapy, for about 12 to 18 weeks, and then stop about three weeks after your last chemotherapy treatment.

Will taking DHA replace my regular cancer treatment?

Absolutely not. This study is testing DHA *in addition* to your standard chemotherapy, not instead of it. Your main cancer treatment will continue as planned by your doctors.