Recruiting

FLX with DOX+TRZ

Sponsor:

St. Boniface Hospital

Code:

NCT04632407

Conditions

Cardiotoxicity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Flax "milk"

Oat fibre "milk"

Study Details

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

Study ID

NCT04632407

Start date

Oct 21, 2020

Status verified date

Nov, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Flax "milk"

See above

Oat fibre "milk"

See above

Primary outcome measure

  • Left ventricular ejection fraction (LVEF) change [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Davinder S Jassal, MD

2042372023djassal@sbgh.mb.ca

Locations

St. Boniface Albrechtsen Research Centre

Recruiting

Winnipeg, Manitoba, Canada, R2E1J7

Contacts

Davinder S Jassal, MD

2042372023djassal@sbgh.mb.ca

More Information

Sponsor

St. Boniface Hospital

Last update posted

Nov 17, 2020

Last verified

Nov, 2020

Keywords

  • Cardiotoxicity
  • Chemotherapy
  • Flaxseed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Boniface Hospital on 2020-11-17.