Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorUniversity of Alberta

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Structured Exercise Training

    Behavioral

    Participants will complete 12-weeks of supervised, structured moderate-to-high intensity aerobic and resistance training three times per week.

  • Group-based Yoga and Stretching

    Behavioral

    Participants will complete 12-weeks of supervised group-based yoga and stretching once per week.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental Arm: Structured Exercise TrainingExperimental treatment 1 intervention
Group B: Active Comparator: Group-based Yoga and StretchingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak arterio-venous oxygen content difference

Peak exercise arterio-venous oxygen content difference assessed using whole-body exercise MRI

Time frame
12 Weeks
2

Peak cardiac output

Peak exercise cardiac output assessed using whole-body exercise MRI

Time frame
12 Weeks

Secondary outcomes

1

Peak volume of oxygen uptake

Peak volume of oxygen uptake assessed from a maximal cardiopulmonary exercise test

Time frame
12 Weeks
2

Peak diffusive muscle oxygen conductance

Calculated diffusive muscle oxygen conductance assessed using whole-body exercise MRI

Time frame
12 Weeks
3

Peak stroke volume

Peak exercise stroke volume assessed using whole-body exercise MRI

Time frame
12 Weeks
4

Aerobic endurance

Walk distance measured during a six minute walk test

Time frame
12 Weeks

Other outcomes

1

Habitual Physical Activity

Time spent in moderate-to-vigorous physical activity over 7 days of objective monitoring (Fitbit)

Time frame
12 Weeks
2

Fasting Lipids

A fasting blood test will be used to measure concentrations of high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol and triglycerides

Time frame
12 Weeks
3

Fasting Glycaemic Control

A fasting blood test will be used to measure concentrations of fasting plasma glucose and fasting insulin

Time frame
12 Weeks
4

Fasting Insulin Resistance

Fasting insulin resistance will be calculated from fasting plasma glucose and insulin concentrations using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) method.

Time frame
12 Weeks

Sponsors and contacts

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University of Alberta

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator