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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06925529
Registration number
NCT06925529
Ethics application status
Date submitted
20/03/2025
Date registered
13/04/2025
Date last updated
13/04/2025
Titles & IDs
Public title
Exercise to Improve Neurovascular Function in Breast Cancer Survivors
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Scientific title
Protecting Neurovascular Function In lOng-term Breast caNcer Survivors With ExercisE tRaining - The PIONEER Study
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Secondary ID [1]
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114949
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Secondary ID [2]
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P11723
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Universal Trial Number (UTN)
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Trial acronym
PIONEER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Survivorship
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Cardio-Oncology Rehabilitation and Exercise Programme
No intervention: Usual Care - Participants randomised to the usual care group will be provided with their usual care by their usual healthcare professional(s). The usual care group will not be prescribed any exercise training through the study. However, they will be informed that they should aim to achieve the physical activity and exercise guidelines for Australian adults or older adults depending on their age (Care, 2024). The usual care group will not be monitored throughout the study intervention period, except for the reporting of adverse events where necessary.
Experimental: Cardio-Oncology Rehabilitation and Exercise Programme - Participants 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.
BEHAVIORAL: Cardio-Oncology Rehabilitation and Exercise Programme
Participants 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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in Neurovascular Function Measured via MRI-Derived Total Cerebral Blood Flow at 6 Months
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Assessment method [1]
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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).
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Change from Baseline in Neurocognitive Function Measured via the Montreal Cognitive Assessment at 6 Months
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Assessment method [1]
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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.
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
* Female
* Aged 45 - 75 years old at study enrolment
* Diagnosed with stage 1 - 3 breast cancer 5 - 10 years prior to study enrolment
* Have received potentially toxic chemotherapy, including:
* Anthracycline (any dose)
* Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
* Tyrosine kinase inhibitors (e.g. sunitinib) OR
* Left chest radiotherapy
* = 1 'traditional' CVD risk factor (I.e., Hypertension, dyslipidaemia, diabetes, obesity, smoking or family history of CVD) (Mehta et al., 2023)
* 'Physically inactive', not meeting Australian physical activity guidelines for adults or regularly participating in structured exercise training (Care, 2024).
* Eligible for Medicare
* Willing to provide written informed consent to participate in the study
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Minimum age
45
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Diagnosed CVD or stage B heart failure
* Diagnosed neurocognitive or cerebrovascular disease
* Diagnosed atrial fibrillation or cardiac arrythmia
* BMI = 18.4 kg·m2
* Any other contraindications to exercise testing and training that make participation in this study unsafe, determined through medical screening
* Unable to speak and understand the English language
* Contraindication to brain MRI
* Participating in another clinical research trial where randomized treatment would be unacceptable
* Oncologic (or other) life expectancy = 12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Principal Investigator) that it is not appropriate for the patient to participate in this trial.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
7/04/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/08/2026
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06925529
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Erin Howden, A/Professor
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Address
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Baker Heart and Diabetes Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Erin Howden, A/Professor
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Address
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Country
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Phone
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+61 38532 1861
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices).
Supporting document/s available: Study protocol
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication.
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Available to whom?
Researchers who provide a methodologically sound proposal may request access to the data from the principal investigator of the study (A/Professor Erin Howden). Proposals should be directed to
[email protected]
initially.
Data requestors will also need to sign a data sharing agreement with the Baker Heart and Diabetes Institute. This contract will be reviewed by the Baker Heart and Diabetes Institute's Contracts and Compliance Manager.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06925529
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