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

NCT ID: NCT04632407

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2022-12-31

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.

Conditions

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Cardiotoxicity

Keywords

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Cardiotoxicity Chemotherapy Flaxseed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study participants will be randomized to either oat fibre "milk" or flax "milk"
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The 2 products (oat fibre "milk" and flax "milk") are assigned a unique ID code.

Study Groups

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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.

Group Type EXPERIMENTAL

Flax "milk"

Intervention Type DIETARY_SUPPLEMENT

See above

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.

Group Type EXPERIMENTAL

Oat fibre "milk"

Intervention Type DIETARY_SUPPLEMENT

See above

Interventions

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Flax "milk"

See above

Intervention Type DIETARY_SUPPLEMENT

Oat fibre "milk"

See above

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Davinder S. Jassal

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davinder S Jassal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface Albrechtsen Research Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Davinder S Jassal, MD

Role: CONTACT

Phone: 2042372023

Email: [email protected]

Facility Contacts

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Davinder S Jassal, MD

Role: primary

Other Identifiers

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CT/2019/CANFLAX

Identifier Type: -

Identifier Source: org_study_id