Clinical trial NCT06595147: Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
Official title: Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Disability Physical
Heart Failure
Cardiotoxicity
Keywords: Exercise Training
Fitness
Heart
Muscle
Cancer
Survivorship
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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

Primary outcomes:
measure: Peak arterio-venous oxygen content difference
timeFrame: 12 Weeks
measure: Peak cardiac output
timeFrame: 12 Weeks
Secondary outcomes:
measure: Peak volume of oxygen uptake
timeFrame: 12 Weeks
measure: Peak diffusive muscle oxygen conductance
timeFrame: 12 Weeks
measure: Peak stroke volume
timeFrame: 12 Weeks
measure: Aerobic endurance
timeFrame: 12 Weeks
measure: Physical Function
timeFrame: 12 Weeks
measure: Skeletal muscle volume
timeFrame: 12 Weeks
measure: Skeletal muscle myosteatosis
timeFrame: 12 Weeks
measure: Skeletal muscle fibrosis
timeFrame: 12 Weeks
measure: Calf muscle aerobic capacity
timeFrame: 12 Weeks
measure: Calf muscle oxygen extraction
timeFrame: 12 Weeks
measure: Calf muscle oxygen diffusive conductance
timeFrame: 12 Weeks
measure: Calf muscle metabolism
timeFrame: 12 Weeks
measure: 10-year Framingham Risk Score
timeFrame: 12 Weeks
Other outcomes:
measure: Habitual Physical Activity
timeFrame: 12 Weeks
measure: Fasting Lipids
timeFrame: 12 Weeks
measure: Fasting Glycaemic Control
timeFrame: 12 Weeks
measure: Fasting Insulin Resistance
timeFrame: 12 Weeks
measure: C-reactive protein
timeFrame: 12 Weeks
measure: Resting blood pressure
timeFrame: 12 Weeks
measure: Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
timeFrame: 12 Weeks
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: