Can Flaxseed Prevent Broken Hearts in Women With Breast Cancer Study?

Study Overview
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Brief Summary
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The main goal of the current research program is to examine the use of nutraceuticals, in particular flaxseed (FLX), in the prevention of Doxorubicin and Trastuzumab (DOX+TRZ) mediated cardiotoxicity in the clinical setting. As Manitoba continues to be one of the top FLX producers in the world, there is an increasing public awareness of the importance of the consumption of this whole grain commodity in the prevention of cancer and cardiovascular disease. In North America, approximately 1 in 8 women will develop breast cancer and will receive treatment with DOX+TRZ. Although women with breast cancer are at risk of developing heart failure due to chemotherapy, FLX has the capacity to prevent this outcome. The purpose of the CANFLAX study is to establish FLX milk as an effective method in preventing heart failure in women with breast cancer.

Detailed Description
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Cardiovascular toxicity is a potential short and long-term complication of anti-cancer therapy with DOX+TRZ in the breast cancer setting. Although FLX is commonly consumed in up to 30% of women with breast cancer to improve overall disease burden and survival, it is important to study whether this natural dietary agent can also reduce the cardiotoxic side effects of DOX+TRZ in the clinical setting. The investigators hypothesize that the prophylactic consumption of FLX milk will prevent adverse cardiovascular remodeling and improve overall functional capacity in women with breast cancer receiving DOX+TRZ therapy. The two specific aims of the CANFLAX study include: Aim 1: FLX milk will prevent the development of heart failure in women with early stage breast cancer (EBC) who are treated with DOX+TRZ based chemotherapy; and Aim 2: FLX milk will improve cardiac functional capacity in this patient population.

Official Title
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Can Flaxseed Prevent Broken Hearts in Women With Breast Cancer Study?

Conditions
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Cardiotoxicity

Intervention / Treatment
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* Dietary Supplement: Flax milk
* Dietary Supplement: Oat fibre milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) ≥18 years old; ii) women with newly diagnosed early stage breast cancer (Stage I-IIIA) iii) chemotherapy with 5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or adriamycin and cyclophosphamide (AC) for 4 months Exclusion Criteria: i) pre-existing diagnosis of heart failure and/or LVEF<40% ii) pre-existing use of anti-hypertensive agents including ACE inhibitors (ACEi) or beta blockers iii) planned use of any herbal/antioxidant/fatty acid/nutritional supplements at any time in the duration of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study participants will be randomized to either oat fibre milk or flax milk
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flax milk<br>A total of 30 women will receive flax (FLX) milk on a daily basis for a total of 4 months. The FLX milk will be composed of BevPur (30 mesh FLX), various gums for texture, vanilla flavoring, several minor ingredients, and water. Each serving contains 15 grams of FLX and 3.75 grams of Omega-3. | Dietary Supplement: Flax milk<br>* See above<br>|
| Experimental: Oat fibre milk<br>A total of 30 women will receive the oat fiber milk on a daily basis for a total of 4 months. The oat fibre milk will be composed of oat fibre, various gums for texture, vanilla flavoring, several minor ingredients, and water. | Dietary Supplement: Oat fibre milk<br>* See above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) change | Left ventricular ejection fraction (LVEF %) will be evaluated using transthoracic echocardiography at baseline and 12 month follow-up. A difference in LVEF>10% from baseline will be considered significant. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiotoxicity, Chemotherapy, Flaxseed