NCT06925529: PIONEER

Exercise to Improve Neurovascular Function in Breast Cancer Survivors

Not yet recruiting NA Last updated 2 October 2025

What this trial tests

NA trial testing Cardio-Oncology Rehabilitation and Exercise Programme in Breast Cancer Survivorship in 40 participants. Not yet recruiting.

Timeline

3 November 2025

Primary endpoint
6 July 2026

29 August 2026

Quick facts

Lead sponsor	Baker Heart and Diabetes Institute
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	40
Start date	3 November 2025
Primary completion	6 July 2026
Estimated completion	29 August 2026
Sites	1 location across Australia

Drugs / interventions tested

• Cardio-Oncology Rehabilitation and Exercise Programme

Conditions studied

• Breast Cancer Survivorship — all drugs for Breast Cancer Survivorship →

Sponsor

Baker Heart and Diabetes Institute

Who can join

Adults 45 to 75, female only, with Breast Cancer Survivorship. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.