Breast Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALAerobic Exercise
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
Sponsors
Oslo University Hospital
Memorial Sloan Kettering Cancer Center
University of Oslo
Norwegian School of Sport Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
28 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Eligible BCS must be listed in the Norwegian Cancer registry * Female * Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012 * 60 years or younger at the time of diagnosis * received anthracycline-based chemotherapy as a part of their treatment history * signed informed consent and medical doctors approveal of participation prior to inclusion
Exclusion criteria
* Received Herceptin * Diagnosed with stage IV breast cancer * Relapse since diagnosis * A history, or current presence, of another diagnosis of invasive cancer of any kind * Selfreported severe fatigue * present with any uncontrolled- or recent cardiovascular disease, has undergone heart surgery or uses a pacemaker * currently exercising more than 90 minutes per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2peak | From baseline to five months (post-intervention) | Peak oxygen uptake during a treadmill based cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic- and diastolic longitudinal strain | From baseline to five months (post-intervention) | Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography |
| Lean body mass | From baseline to five months (post-intervention) | Body composition will be assessed by dual x-ray absorptiometry |
| Fat mass | From baseline to five months (post-intervention) | Body composition will be assessed by dual x-ray absorptiometry |
| Blood volume | From baseline to five months (post-intervention) | Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method |
| Systolic- and diastolic heart chamber dimensions | From baseline to five months (post-intervention) | Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography |
| Muscle fiber area | From baseline to five months (post-intervention) | Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry |
| Muscle mitochondria mass | From baseline to five months (post-intervention) | Change in mitochondrial proteins will be assessed in muscle biopsies using western blot |
| Quality of life: Quality of Life Questionnaire (QLQ) C-30 | From baseline to five months (post-intervention) | Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30 |
| Genome-wide DNA methylation and gene expression | From baseline to five months (post-intervention) | For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA |
| Muscle fiber type | From baseline to five months (post-intervention) | Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry |
Countries
Norway
Outcome results
None listed