The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer
In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only. The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
210
Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
Norwegian School of Sport Sciences
Oslo, Norway
Change in VO2peak
Peak oxygen uptake during a treadmill based cardiopulmonary exercise test
Time frame: From baseline to five months (post-intervention)
Systolic- and diastolic heart chamber dimensions
Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Time frame: From baseline to five months (post-intervention)
Systolic- and diastolic longitudinal strain
Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Time frame: From baseline to five months (post-intervention)
Lean body mass
Body composition will be assessed by dual x-ray absorptiometry
Time frame: From baseline to five months (post-intervention)
Fat mass
Body composition will be assessed by dual x-ray absorptiometry
Time frame: From baseline to five months (post-intervention)
Blood volume
Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method
Time frame: From baseline to five months (post-intervention)
Muscle fiber type
Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Time frame: From baseline to five months (post-intervention)
Muscle fiber area
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Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Time frame: From baseline to five months (post-intervention)
Muscle mitochondria mass
Change in mitochondrial proteins will be assessed in muscle biopsies using western blot
Time frame: From baseline to five months (post-intervention)
Quality of life: Quality of Life Questionnaire (QLQ) C-30
Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30
Time frame: From baseline to five months (post-intervention)
Genome-wide DNA methylation and gene expression
For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA
Time frame: From baseline to five months (post-intervention)