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

NCT04632407 | Unknown DMC

• 1 other identifier: CT/2019/CANFLAX
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity

Keywords

Cardiotoxicity; Chemotherapy; Flaxseed

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Flax "milk"

EXPERIMENTAL

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"

Oat fibre "milk"

EXPERIMENTAL

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"

Interventions

Flax "milk" DIETARY_SUPPLEMENT

See above

Flax "milk"

Oat fibre "milk" DIETARY_SUPPLEMENT

See above

Oat fibre "milk"

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

St. Boniface Albrechtsen Research Centre

Winnipeg, Manitoba, R2E1J7, Canada

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Davinder S Jassal, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Davinder S Jassal, MD

CONTACT

2042372023; djassal@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The 2 products (oat fibre "milk" and flax "milk") are assigned a unique ID code.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: The study participants will be randomized to either oat fibre "milk" or flax "milk"

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 17, 2020
• Study Start: October 21, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)