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Trial registered on ANZCTR


Registration number
ACTRN12621001030864
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of exercise on cancer therapy related cardiac dysfunction in women with breast cancer undergoing chemotherapy
Scientific title
Effect of exercise on cancer therapy related cardiac dysfunction in women with breast cancer undergoing chemotherapy
Secondary ID [1] 304674 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
ExCTRCD
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 322633 0
Cardiovascular Disease 322634 0
Hypertension 322635 0
Type 2 Diabetes 322636 0
Condition category
Condition code
Cancer 320252 320252 0 0
Breast
Cardiovascular 320253 320253 0 0
Hypertension
Metabolic and Endocrine 320254 320254 0 0
Diabetes
Cardiovascular 320433 320433 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that will be investigated in this project is exercise. Participants will be randomised to an exercise group (EX) or a standard care group (CON). Participants in the EX group will perform exercise three times per week for eight weeks. Each exercise session will run for 30 minutes and be performed at a moderate intensity (55-70% heart rate (HR) maximum, 40-59% HR reserve). Participants maximum HR will be measured in baseline testing. All participants will perform exercise at the same RELATIVE intensity. Exercise will be continuous aerobic exercise performed on a stationary recumbent cycle ergometer. All exercise session will be supervised face-to-face by an accredited exercise physiologist. All sessions will be delivered individually. All sessions will be performed at the University of South Australia Clinical Trials Facility. Participant adherence to exercise sessions will be determined by number of sessions attended/number of available sessions (24), using a session attendance checklist. Participant HR will be recorded at the 5, 10 15, 20, 25 and 30 minute mark of each exercise session, to determine adherence to the exercise intensity protocol.
Intervention code [1] 321039 0
Prevention
Intervention code [2] 321040 0
Treatment: Other
Intervention code [3] 321041 0
Lifestyle
Comparator / control treatment
Participants in the CON group will undergo standard care treatment. No change to standard care treatment will be made. Standard care includes access to an exercise intervention at the Royal Adelaide Hospital during chemotherapy treatment. No restrictions will be placed on participants regarding the amount of exercise they can perform during the period between baseline and end of intervention testing. Self-reported physical activity will be measured using the International Physical Activity Questionnaire - Short Form, to account for exercise contamination. The exercise intervention included in standard care treatment at the Royal Adelaide Hospital is an individualised exercise intervention involving both aerobic and resistance based exercise, and is offered to participants 3x per week. Attendance to these exercise session is optional. The exercise intervention that will be performed by the EX group is described above, and will consist of continuous aerobic based exercise at moderate intensity, that is relative to the participants baseline exercise testing results.
Control group
Active

Outcomes
Primary outcome [1] 328113 0
Change in Global Longitudinal Strain (GLS) - images obtained via GE Vivid E95 Ultrasound.
Timepoint [1] 328113 0
Baseline, 1 month, 2 months (end of intervention - primary time point), 6 months (4 months after intervention completion).
Primary outcome [2] 328114 0
Change in Left Ventricular Ejection Fraction (LVEF) - images obtained via GE Vivid E95 Ultrasound.
Timepoint [2] 328114 0
Baseline, 1 month, 2 months (end of intervention - primary time point), 6 months (4 months after intervention completion).
Secondary outcome [1] 397698 0
Change in Peak Oxygen Consumption (VO2 Peak) assessed via Parvomedics Trueone 2400 Metabolic Measurement System.
Timepoint [1] 397698 0
Baseline, 1 month, 2 months (end of intervention ), 6 months (4 months after intervention completion).
Secondary outcome [2] 397699 0
Quality of life assessed via EORTC QLQ-C30 ‘quality of life of cancer patients’ questionnaire.
Timepoint [2] 397699 0
Baseline, 1 month, 2 months (end of intervention), 6 months (4 months after intervention completion).
Secondary outcome [3] 397700 0
Fatigue assessed via EORTC QLQ-FA12 ‘cancer related fatigue’ questionnaire.
Timepoint [3] 397700 0
Baseline, 1 month, 2 months (end of intervention), 6 months (4 months after intervention completion).

Eligibility
Key inclusion criteria
Group 1:
- Female.
- 18 years of age or greater.
- Diagnosed with breast cancer and scheduled for anthracycline containing chemotherapy.
- Have either type 2 diabetes mellitus (T2DM) or hypertension (HTN).
- No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias.

Group 2:
- Female.
- 30-70 years of age.
- Have either type 2 diabetes mellitus (T2DM) or hypertension (HTN).
- No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias.
- No history of any cancer and no current cancer diagnosis
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Previous or current history of cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias. This DOES NOT include type 2 diabetes mellitus or hypertension.
2) A physical disability that prevents safe and adequate exercise testing and training.
3) Not meeting inclusion criteria listed above.

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)
Group allocation will be performed by a member of the research team who has no involvement in the screening, enrolment, and baseline testing phases. Therefore, the member of the research team who enrols participants will not be aware of which group the participants will be randomised too.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation performed by a member of the research team not involved in screening, enrolment, and baseline testing. Stratification will be based on age, baseline VO2peak and GLS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations were performed using a decrease in GLS of 10% from baseline as a significant change. Based on the data available in the literature and calculations performed by the biostatistician with reference to Diggle et al. it is proposed that 15 participants per group will be required for 80% power with significance level (alpha) of 0.05. To account for participant attrition, we will aim to recruit 25 participants per group (50 BC patients (25 EX, 25 CON), 50 non-BC patients (25 EX, 25 CON)).
Diggle P, Diggle PJ, Heagerty P, Liang K-Y, Heagerty PJ, Zeger S. Analysis of longitudinal data. Oxford University Press; 2002.

Differences between groups for primary and secondary outcome measures will be assessed using linear mixed effect modelling. A change in GLS of 10% from baseline will be considered significant. Effect sizes and 95% confidence intervals for the primary and secondary outcomes will be presented. Two-sided P value of <0.05 will be considered statistically significant. Regression analyses will be performed to determine associations between GLS, LVEF and VO2 peak at multiple time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19883 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 34584 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 309041 0
University
Name [1] 309041 0
University of South Australia Cancer Research Institute
Address [1] 309041 0
Level 8, HB Building Cnr North Terrace and, Morphett St, Adelaide SA 5000
Country [1] 309041 0
Australia
Funding source category [2] 309042 0
Government body
Name [2] 309042 0
Australia Federal Government - Research Training Scholarship.
Address [2] 309042 0
PO Box 6010
Parliament House
Canberra ACT 2600
Country [2] 309042 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia - City East Campus. Corner of North Terrace and Frome Rd, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 309979 0
None
Name [1] 309979 0
Address [1] 309979 0
Country [1] 309979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308918 0
Central Adelaide Local Health Network Human Research Ethics Committee.
Ethics committee address [1] 308918 0
Port Road
Adelaide SA 5000
Ethics committee country [1] 308918 0
Australia
Date submitted for ethics approval [1] 308918 0
10/12/2020
Approval date [1] 308918 0
15/03/2021
Ethics approval number [1] 308918 0
13976
Ethics committee name [2] 308920 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 308920 0
108 North Terrace, Adelaide, SA, 5000
Ethics committee country [2] 308920 0
Australia
Date submitted for ethics approval [2] 308920 0
15/04/2021
Approval date [2] 308920 0
21/04/2021
Ethics approval number [2] 308920 0
203909

Summary
Brief summary
This study aims to investigate the impact of exercise on the risk of developing cardiac dysfunction in women who have cardiovascular risk factors and are undergoing chemotherapy for breast cancer.

Who is it for?
You may be eligible for this study if you are a woman aged 18 or over who has either Type 2 Diabetes or hypertension, and have been diagnosed with breast cancer and scheduled for anthracycline or trastuzumab containing chemotherapy.

Study details
Participants will be randomly allocated to perform moderate intensity exercise three times per week for eight weeks, or to a control arm where they will receive standard care. All participants regardless of their group allocation will attend 4 testing visits over 6 months, where they will undergo cardiac imaging, exercise testing and questionnaires.

Data collected from this study will inform researchers of the role of exercise in preventing cardiac dysfunction from potentially toxic anti-cancer agents.
Trial website
https://www.unisa.edu.au/research/research-volunteers/cardiovascular-health-and-function-research-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112342 0
Mr James Murray
Address 112342 0
University of South Australia City East Campus
Cnr of Frome Road and North Terrace, Adelaide, SA, 5001
Country 112342 0
Australia
Phone 112342 0
+610883022570
Fax 112342 0
Email 112342 0
james.murray@mymail.unisa.edu.au
Contact person for public queries
Name 112343 0
Mr James Murray
Address 112343 0
University of South Australia City East Campus
Cnr of Frome Road and North Terrace, Adelaide, SA, 5001
Country 112343 0
Australia
Phone 112343 0
+610883022570
Fax 112343 0
Email 112343 0
james.murray@mymail.unisa.edu.au
Contact person for scientific queries
Name 112344 0
Mr James Murray
Address 112344 0
University of South Australia City East Campus
Cnr of Frome Road and North Terrace, Adelaide, SA, 5001
Country 112344 0
Australia
Phone 112344 0
+610883022570
Fax 112344 0
Email 112344 0
james.murray@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data analyses will be performed on group data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results