Trial Review

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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
16/02/2023
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 in group 1 will have a choice to participate in an exercise intervention (EX) or standard care (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. Participants in group 2 will undergo the same exercise program, however following a randomised crossover design. Participants in group 2 will be randomised to either an exercise or non-exercise arm first, and then swap into the other group at the completion of the first arm (either exercise and non-exercise). A minimum of 4-weeks wash out will occur before swapping into the other arm, with no maximum wash out period. Testing, outcome measures and exercise procedures will remain exactly the same as per above for group 1.
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), 5 months (3 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), 5 months (3 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 ), 5 months (3 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), 5 months (3 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), 5 months (3 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.
- 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.
- 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
Sex
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
Non-randomised 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)
Participant choice of preferred group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Group 1 will select their preferred group (non-randomised), while group 2 will undergo crossover assignment (randomised).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group 1 will follow a non-randomised, pre-post design, and be presented as a series of case studies. As such, no sample size calculations are relevant for this group. Group 2 following a randomised crossover design. The mean and standard deviation of GLS from each arm of the first three completed participants was used to retrospectively calculate sample size, using a matched-pair t-test. With a standard deviation of the difference in means between groups of 1.53, nine participants were required to provide 80% power to detect a mean difference of 1.7 between groups (10% relative change in GLS from a baseline GLS of -17%), with an alpha of 0.05.
As data will be presented case by case for group 1, no grouped analysis will be performed. All variables will be tabulated and presented as raw values. Relative change from baseline will be calculated for echocardiography and cardiorespiratory fitness variables and presented as a percentage (%). For group 2, continuous variables will be expressed as mean?±?standard deviation. A linear mixed effect model will be used to compare outcomes between (exercise vs control) and within (pre- vs. post-intervention) groups for echocardiographic and cardiorespiratory fitness variables. For all analyses, participant id will be considered as a random effect. All participants who complete at least one arm of the trial will be included in the analysis. Pearson’s (r) correlation will be performed to determine the association between relative change in GLS and VO2peak. All data will be analysed using Stata statistical software (v17.1, Stata Corp, TX, USA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2021
Actual
9/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19883 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 22419 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 22420 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 22421 0
Western Hospital - Henley Beach - Henley Beach
Recruitment postcode(s) [1] 34584 0
5000 - Adelaide
Recruitment postcode(s) [2] 37583 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 37584 0
5011 - Woodville
Recruitment postcode(s) [4] 37585 0
5022 - Henley Beach

Funding & Sponsors
Funding source category [1] 309041 0
University
Name [1] 309041 0
University of South Australia Cancer Research Institute
Country [1] 309041 0
Australia
Funding source category [2] 309042 0
Government body
Name [2] 309042 0
Australia Federal Government - Research Training Scholarship.
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
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
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
Trial website
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
[email protected]
Contact person for public queries
Name 112343 0
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
[email protected]
Contact person for scientific queries
Name 112344 0
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of Aerobic Training on Cardiovascular Function, Fitness, and Patient Reported Outcomes During Anthracycline Chemotherapy: A Case Series in Women With Breast Cancer.2023https://dx.doi.org/10.1177/15347354231210874
N.B. These documents automatically identified may not have been verified by the study sponsor.