Study Rationale:
Breast cancer survivors are more likely to develop cardiovascular disease (CVD) or neurocognitive disease than age-matched counterparts without a history of cancer diagnosis. Some anti-cancer treatments cause damage to the cells of heart and the walls of blood vessels, which may exacerbate neurovascular dysfunction and cancer-related cognitive impairment (symptoms such as 'chemo-brain'), as well as accelerating the onset of neurocognitive disease. Therefore, effective policies and therapeutic strategies are needed to minimize neurovascular dysfunction and neurocognitive disease in at-risk populations like breast cancer survivors.
Regular exercise training is effective in slowing or preventing the development of CVD. Furthermore, higher fitness levels are associated with lower dementia risk in older adults, which may be due to better neurovascular function. However, whether exercise training incorporated into a Cardio-Oncology Rehabilitation and Exercise (CORE) programme can improve neurovascular function in breast cancer survivors is currently unknown. Therefore, the primary aim of this study will be to determine the effect of a CORE programme on neurovascular function in long-term breast cancer survivors.
Study Description:
This study will be a randomised controlled trial to investigate the effect of a CORE programme on neurovascular function in long-term breast cancer survivors.
Participants will complete a series of baseline assessments, including lifestyle questionnaires, a cognitive function assessment, dual-energy x-ray absorptiometry (DXA), a cardiopulmonary exercise test (CPET), ultrasound assessments of arterial stiffness and vascular function, and brain magnetic resonance imaging (MRI). Furthermore, participants will wear a blood pressure monitor at home for 24 hours, and a physical activity monitor for seven days.
Following completion of baseline assessments, participants will be randomised to either the CORE program or a 'usual care' group. The CORE program will include a 6-month exercise training program supervised by an Exercise Physiologist at the Baker Heart and Diabetes Institute. The usual care group will carry on with healthcare from their usual healthcare provider(s) for 6 months.
Participants will then complete two follow-up study visits following completion of the 6-month intervention period, with identical procedures to the baseline study visits.
Study Duration:
This study involves two baseline study visits in month 1, followed by two study visits in month 7. Participants randomised to the CORE program will be asked to attend the Baker Heart and Diabetes Institute on a weekly basis for supervised exercise training sessions. However, the supervised exercise training sessions will be provided by a mix of in-person, video-conferencing and tele-health modes depending on each participants availability and needs.
Female
Aged 45 - 75 years old at study enrolment
Diagnosed with stage 1 - 3 breast cancer 5 - 10 years prior to study enrolment
Anthracycline (any dose)
Diagnosed CVD or stage B heart failure
Diagnosed neurocognitive or cerebrovascular disease
Diagnosed atrial fibrillation or cardiac arrythmia
BMI ≤ 18.4 kg∙m2
Parallel
Cardio-Oncology Rehabilitation and Exercise Programme
BehavioralParticipants randomised to the CORE programme will receive exercise training that is analogous to cardiac rehabilitation, but Exercise Physiologists will individualise each training program using the participants baseline CPET results to maximise adherence and improve the effectiveness of the training program beyond typical cardiac rehabilitation programs. An Exercise Physiologist will supervise two training sessions a week and monitor adherence to one other independent session at home each week for the first 12 weeks of the training program whilst exercise frequency, intensity, and time is progressively increased. Supervision of the exercise training will then be stepped down gradually after 12 weeks to a fortnightly check-in to encourage intervention adherence. Patients will be provided with a training calendar and objective tools for tracking physical activity (e.g. heart rate monitor and diary). Adherence will be monitored in real-time using a research web-based platform.
Change from Baseline in Neurovascular Function Measured via MRI-Derived Total Cerebral Blood Flow at 6 Months
The change in neurovascular function will be measured via total cerebral blood flow during brain magnetic resonance imaging (MRI), from pre- to post-study intervention period. Total cerebral blood flow will be measured relative to brain volume via arterial spin labeling and magnetization prepared rapid gradient echo imaging MRI scan sequences. Total cerebral blood flow will be measured in millilitres of blood per 100g of brain tissue per minute (ml.100g.min).
Change from Baseline in Neurocognitive Function Measured via the Montreal Cognitive Assessment at 6 Months
The change in neurocognitive function will be measured via a Montreal Cognitive Assessment (MoCA) score, from pre- to post-study intervention period. The MoCA is paper-based test administered by a certified test administrator and marked on a 30-point scale (0 to 30), with lower scores indicating worse neurocognitive function.
Determing if Changes from Baseline in Cardiorespiratory Fitness measured during Cardiopulomary Exercise Testing Mediate Improvements in Neurocognitive Function Measured via a Montreal Cognitive Assessment at 6 Months
Mediation analysis will be used to identify whether changes cardiorespiratory fitness - measured as maximal ventilatory intake of oxygen in millilitres per minute per kilogram of body mass (ml.min.kg) during a cardiopulmonary exercise test - from baseline to 6 months mediate improvements in neurocognitive function. Neurocognitive function will be measured via a Montreal Cognitive Assessment (MoCA) score, from pre- to post-study intervention period. The MoCA is paper-based test administered by a certified test administrator and marked on a 30-point scale (0 to 30), with lower scores indicating worse neurocognitive function.
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