Status:
NOT_YET_RECRUITING
Exercise to Improve Neurovascular Function in Breast Cancer Survivors
Lead Sponsor:
Baker Heart and Diabetes Institute
Conditions:
Breast Cancer Survivorship
Eligibility:
FEMALE
45-75 years
Phase:
NA
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 an...
Detailed Description
Study Rationale: Breast cancer (BC) is the most common diagnosed cancer in Australian females (BreastScreen Australia Monitoring Report 2024, Summary, 2024). Although the 5-year relative survival fro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06925529
Start Date
November 3 2025
End Date
August 29 2026
Last Update
October 2 2025
Active Locations (1)
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1
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004