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Trial Title:
Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
NCT ID:
NCT06595147
Condition:
Breast Cancer
Disability Physical
Heart Failure
Cardiotoxicity
Conditions: Official terms:
Breast Neoplasms
Cardiotoxicity
Conditions: Keywords:
Exercise Training
Fitness
Heart
Muscle
Cancer
Survivorship
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
All MRI outcomes will be performed blinded to group allocation. Outcome assessors for
post-outcome assessments will be blinded to baseline values.
Intervention:
Intervention type:
Behavioral
Intervention name:
Structured Exercise Training
Description:
Participants will complete 12-weeks of supervised, structured moderate-to-high intensity
aerobic and resistance training three times per week.
Arm group label:
Experimental Arm: Structured Exercise Training
Intervention type:
Behavioral
Intervention name:
Group-based Yoga and Stretching
Description:
Participants will complete 12-weeks of supervised group-based yoga and stretching once
per week.
Arm group label:
Active Comparator: Group-based Yoga and Stretching
Summary:
The chemotherapy medications used for breast cancer treatment are important for achieving
a cure, but a potential side effect is that they can cause a decline in functional
capacity (reduced exercise tolerance and impaired physical function) and increase the
risk of cardiovascular disease. The risks of decreased functional capacity and
cardiovascular disease are highest in breast cancer survivors as they grow older. The
factors causing the decline in functional capacity are not well understood, however they
may be related to a reduction in cardiac function (e.g. decreased pumping ability of the
heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise
training is used for other populations at risk for cardiovascular disease (such as
cardiac rehabilitation), but is not routinely offered to breast cancer survivors.
Therefore this research study wants to test whether exercise training can improve heart
and muscle health, and increase functional capacity in up to 60 older breast cancer
survivors aged >60 years old who previously received chemotherapy drugs that can affect
the heart.
The purpose of this study is to compare two rehabilitation approaches: a 12-week
structured exercise training program or a 12-week stretching-yoga program. The
investigators want to compare whether these programs can improve functional capacity, and
heart and skeletal muscle function. To do this, some of the participants in this study
will be randomly enrolled in the structured exercise training program and others will be
randomly enrolled in the stretching-yoga program.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥60 years
- Previously diagnosed with early-stage (I-III) BC
- Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based
chemotherapy or trastuzumab-based biological therapy).
Exclusion Criteria:
- Have a history of coronary artery disease, heart failure, persistent and permanent
arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive
pulmonary disease
- Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST
segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
- Have any research MRI contraindications (e.g. any type of pacemaker), or any
orthopedic limitation preventing exercise testing
- Currently performing structured exercise training (defined as ≥30 mins/day of
moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
- Are unwilling to be randomized to either ExT or STRETCH
Gender:
Female
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Zip:
T6G1C9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Stephen Foulkes, PhD
Phone:
+1-780-668-1669
Email:
ageheart@ualberta.ca
Investigator:
Last name:
Mark Haykowsky, PhD
Email:
Principal Investigator
Investigator:
Last name:
Edith Pituskin, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Richard B Thompson, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Margaret McNeely, PhD
Email:
Sub-Investigator
Start date:
July 1, 2024
Completion date:
December 20, 2025
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06595147
