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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiotoxicity
• Intervention / Treatment: Dietary supplement: Flax "milk"; Dietary supplement: Oat fibre "milk"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davinder S Jassal, MD; Phone Number: 2042372023; Email: djassal@sbgh.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2E1J7
      • Recruiting
      • St. Boniface Albrechtsen Research Centre
      • Contact: Davinder S Jassal, MD; Phone Number: 2042372023; Email: djassal@sbgh.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flax "milk"; 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"; See above
Experimental: Oat fibre "milk"; 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"; See above

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Investigators: Principal Investigator: Davinder S Jassal, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Chemotherapy; Cardiotoxicity; Flaxseed
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Cardiotoxicity
• Other Study ID Numbers: CT/2019/CANFLAX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No