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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

Titles & IDs

Public title

Exercise to Improve Neurovascular Function in Breast Cancer Survivors

Scientific title

Protecting Neurovascular Function In lOng-term Breast caNcer Survivors With ExercisE tRaining - The PIONEER Study

Secondary ID [1]

114949

Secondary ID [2]

P11723

Universal Trial Number (UTN)

Trial acronym

PIONEER

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast Cancer Survivorship

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

BEHAVIORAL

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change from Baseline in Neurovascular Function Measured via MRI-Derived Total Cerebral Blood Flow at 6 Months

Timepoint [1]

6 months

Secondary outcome [1]

Change from Baseline in Neurocognitive Function Measured via the Montreal Cognitive Assessment at 6 Months

Timepoint [1]

6 months

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

Minimum age

45 Years

Maximum age

75 Years

Sex

Females

Can healthy volunteers participate?

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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

7/04/2025

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

29/08/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Baker Heart and Diabetes Institute - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

Baker Heart and Diabetes Institute

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/study/NCT06925529

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Erin Howden, A/Professor

Address

Baker Heart and Diabetes Institute

Country

Phone

Fax

Contact person for public queries

Name

Erin Howden, A/Professor

Address

Country

Phone

+61 38532 1861

Fax

[email protected]

Contact person for scientific queries

Data sharing statement

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

Register a trial

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06925529