None listed
Conditions
Brief summary
This study aims to investigate the impact of exercise on the risk of developing cardiac dysfunction in women undergoing chemotherapy for breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 or over who has been diagnosed with breast cancer and scheduled for anthracycline or trastuzumab containing chemotherapy, or a women aged 30 or over who does not have any history of heart disease. Study details Participants will have a choice to perform moderate intensity exercise three times per week for eight weeks, or to receive standard care. All participants regardless of their group allocation will attend 4 testing visits over 6 months, where they will undergo cardiac imaging, exercise testing and questionnaires. Data collected from this study will inform researchers of the role of exercise in preventing cardiac dysfunction from potentially toxic anti-cancer agents.
Interventions
The intervention that will be investigated in this project is exercise. Participants in group 1 will have a choice to participate in an exercise intervention (EX) or standard care (CON). Participants in the EX group will perform exercise three times per week for eight weeks. Each exercise session will run for 30 minutes and be performed at a moderate intensity (55-70% heart rate (HR) maximum, 40-59% HR reserve). Participants maximum HR will be measured in baseline testing. All participants will
The intervention that will be investigated in this project is exercise. Participants in group 1 will have a choice to participate in an exercise intervention (EX) or standard care (CON). Participants in the EX group will perform exercise three times per week for eight weeks. Each exercise session will run for 30 minutes and be performed at a moderate intensity (55-70% heart rate (HR) maximum, 40-59% HR reserve). Participants maximum HR will be measured in baseline testing. All participants will perform exercise at the same RELATIVE intensity. Exercise will be continuous aerobic exercise performed on a stationary recumbent cycle ergometer. All exercise session will be supervised face-to-face by an accredited exercise physiologist. All sessions will be delivered individually. All sessions will be performed at the University of South Australia Clinical Trials Facility. Participant adherence to exercise sessions will be determined by number of sessions attended/number of available sessions (24), using a session attendance checklist. Participant HR will be recorded at the 5, 10 15, 20, 25 and 30 minute mark of each exercise session, to determine adherence to the exercise intensity protocol. Participants in group 2 will undergo the same exercise program, however following a randomised crossover design. Participants in group 2 will be randomised to either an exercise or non-exercise arm first, and then swap into the other group at the completion of the first arm (either exercise and non-exercise). A minimum of 4-weeks wash out will occur before swapping into the other arm, with no maximum wash out period. Testing, outcome measures and exercise procedures will remain exactly the same as per above for group 1.
Sponsors
University of South Australia
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Group 1: - Female. - 18 years of age or greater. - Diagnosed with breast cancer and scheduled for anthracycline containing chemotherapy. - No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias. Group 2: - Female. - 30-70 years of age. - No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias. - No history of any cancer and no current cancer diagnosis
Exclusion criteria
1) Previous or current history of cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias. This DOES NOT include type 2 diabetes mellitus or hypertension. 2) A physical disability that prevents safe and adequate exercise testing and training. 3) Not meeting inclusion criteria listed above.
Outcome results
None listed