Cardiotoxicity
Conditions
Keywords
Cardiotoxicity, Chemotherapy, Flaxseed
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTFlax milk
See above
DIETARY_SUPPLEMENTOat fibre milk
See above
Sponsors
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The 2 products (oat fibre milk and flax milk) are assigned a unique ID code.
Intervention model description
The study participants will be randomized to either oat fibre milk or flax milk
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction (LVEF) change | 1 year | 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. |
Countries
Canada
Contacts
Primary ContactDavinder S Jassal, MD
Outcome results
None listed