Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001602415
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
21/11/2016
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise and the Prevention of Heart Failure in Breast Cancer Patients.
Scientific title
Identification of chemotherapy-induced cardiac damage using novel exercise magnetic resonance imaging in breast cancer patients and exercise training for prevention; a pilot study.
Secondary ID [1] 290293 0
None
Universal Trial Number (UTN)
U1111-1188-5025
Trial acronym
ECR: Exercise for Cardiac Reserve
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 300530 0
Heart Failure 300531 0
Anthracycline based chemotherapy regimen 300532 0
Condition category
Condition code
Cancer 300393 300393 0 0
Breast
Cardiovascular 300394 300394 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise training will be individualised for each participant based upon the cardiopulmonary exercise testing and three-repetition maximum test. Each participant will complete two supervised exercise sessions by an accredited exercise physiologist (4+ years experience sports medicine/oncology) for 60 minutes and one unsupervised home-based exercise each week for approximately 100 minutes. Participants will perform the exercise training at Baker IDI Heart and Diabetes Institute Specialist Clinic gymnasium and will be instructed to perform the aerobic exercise training program (32 minutes) and the resistance training program (28 minutes). The aerobic training program consists of interval stationary cycling beginning at 70% of their peak oxygen consumption (as determined by the cardiopulmonary exercise testing) measured in workload (watts) and progressed each week for 12 weeks. The resistance training program will consist of 4-5 exercises, 3 sets of 12-15 repetitions with a 30 second recovery in between each set. The load (kilograms) and intensity will start at 60-70% of one-repetition maximum and increase by 10 percentage each week. Both programs will follow a periodisation method that accounts for chemotherapy related fatigue, sickness and illness, specifically during the week of chemotherapy administration.
At home, participants will complete continuous walking at a moderate intensity (55%-70% of VO2peak) for 100 minutes.


Adherence will be monitored. The accredited exercise physiologist completes clinical notes after each session (exercise training sheet, exercise diary). Each participant will complete a total of 24 sessions (supervised by an accredited exercise physiologist) and 12 unsupervised sessions)
Intervention code [1] 296097 0
Prevention
Intervention code [2] 296098 0
Lifestyle
Comparator / control treatment
The control group will undergo testing at baseline and three weeks following the last cycle of anthracycline.
They wont be following the personalised exercise program but are encouraged to continue exercising during treatment.
Control group
Active

Outcomes
Primary outcome [1] 299838 0
Cardiac function (ejection fraction) during exercise magnetic resonance.
Timepoint [1] 299838 0
At baseline and 3 weeks after the last cycle of anthracycline chemotherapy
Secondary outcome [1] 328734 0
Peak VO2 = Oxygen uptake measured at maximum exercise. This will be assessed with a cardiopulmonary exercise test on an upright cycle ergometer.
Timepoint [1] 328734 0
At baseline and 3 weeks after the last cycle of anthracycline chemotherapy
Secondary outcome [2] 328735 0
Adherence to exercise as % of planned days completed.
The accredited exercise physiologist completes clinical notes after each session and the participant keeps an exercise diary.. Each participant will complete a total of 24 sessions (supervised by an accredited exercise physiologist) and 12 unsupervised sessions).
Timepoint [2] 328735 0
Throughout the exercise intervention from baseline to follow-up.
Secondary outcome [3] 329463 0
Echocardiographic assessment of Left Ventricular Systolic function (ejection fraction).
Timepoint [3] 329463 0
At baseline and 3 weeks after the last cycle of anthracycline chemotherapy.

Eligibility
Key inclusion criteria
Diagnosed with Breast Cancer
Scheduled for Anthracycline-based chemotherapy.
Capable of walking up two flights of stairs
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Sustained irregular heartbeat (eg atrial fibrillation).
Contraindication to Cardiac MRI such as implanted metallic device (eg pacemaker).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participant can chose if they would like to be part of the exercise or the control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: We recently used exercise CMR to demonstrate that peak-exercise EF% reduced 7.1% in 14 athletes after an endurance sporting event (p<0.0001) whilst resting EF% was unchanged. In moderate-sized cohorts (n=49) of breast cancer patients resting EF% may be reduced post anthracycline therapy but we anticipate that exercise CMR is more sensitive. Anticipating a reduction in peak exercise EF% of 7% and a 50% attenuation of this effect with the exercise intervention (ie. EF reduced by 3.5% during exercise) would be identified with 95% power with 12 subjects in the intervention and control groups. Accounting for the possibility of 15% attrition we will increase this sample to 30; 15 exercisers and 15 controls.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/11/2015
Date of last participant enrolment
Anticipated
28/02/2017
Actual
2/03/2017
Date of last data collection
Anticipated
30/06/2017
Actual
6/06/2017
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6851 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 6852 0
The Alfred - Prahran
Recruitment hospital [3] 6853 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 6854 0
Cabrini Brighton - Brighton
Recruitment postcode(s) [1] 14516 0
3065 - Fitzroy
Recruitment postcode(s) [2] 14517 0
3004 - Prahran
Recruitment postcode(s) [3] 14518 0
3000 - Melbourne
Recruitment postcode(s) [4] 14519 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 294670 0
Charities/Societies/Foundations
Name [1] 294670 0
The Australian National Heart Foundation Future Leader Fellowship
Country [1] 294670 0
Australia
Funding source category [2] 294798 0
Charities/Societies/Foundations
Name [2] 294798 0
The Jack Brockhoff Foundation
Country [2] 294798 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Research Institute
Address
75 Commercial Road, Melbourne, Victoria 3004, Australia
Country
Australia
Secondary sponsor category [1] 293521 0
Hospital
Name [1] 293521 0
St Vincent's Public Hospital Melbourne
Address [1] 293521 0
41 Victoria Parade
Fitzroy VIC 3065
Country [1] 293521 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296101 0
HREC of Alfred Health
Ethics committee address [1] 296101 0
The Alfred Hospital
Ground Floor, Linay Pavilion,
55 Commercial Road, Melbourne Victoria 3004
Ethics committee country [1] 296101 0
Australia
Date submitted for ethics approval [1] 296101 0
25/06/2015
Approval date [1] 296101 0
17/07/2015
Ethics approval number [1] 296101 0
Project 269/15

Summary
Brief summary
This study aims to determine the effect of exercise training on heart function in breast cancer patients undergoing Anthracycline based chemotherapy and to evaluate the use of exercise Cardiac Magnetic Resonance, a novel imaging technique.

Who is it for?
You may be eligible to join this study if you are between the ages 18 and 70 years old, have been diagnosed with breast cancer and are scheduled for Anthracycline-based chemotherapy.

Study details
Participants can chose which group they wish to join.
Participants can select the intervention group where they will follow a personalised exercise program 2 times per week for 60minutes at the Baker IDI Heart and Diabetes institute and one home based (unsupervised) session for 100min for the duration of their Anthracycline chemotherapy. Whilst participants who elect to be in the control group will not follow an exercise program but are encouraged to exercise at their discretion. All participants will undergo an echocardiogram, VO2 max test and exercise Cardiac Magnetic Resonance (CMR) at baseline and 3 weeks after the last anthracycline treatment cycle. The exercise CMR is a novel technique hypothesized to aid in earlier diagnosis of heart failure. Participants will pedal a specially adapted cycle while lying in the narrow tube of the MRI machine.
Trial website
https://bakeridi.edu.au/research/clinical-trials
Trial related presentations / publications
Public notes
Attachments [1] 1193 1193 0 0
/AnzctrAttachments/371620-Fast_Facts_for_referring_Doctors-_Exercise_breast_Cancer_study[1].pdf (Other)
Attachments [2] 1194 1194 0 0
/AnzctrAttachments/371620-Patient_Consent_for_contact_Ex_Breast_Cancer_study[1].pdf (Supplementary information)
Attachments [3] 1195 1195 0 0
/AnzctrAttachments/371620-PICF.269.15 version 4 18th of August 2016 .pdf (Participant information/consent)

Contacts
Principal investigator
Name 69538 0
A/Prof Andre La Gerche
Address 69538 0
Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4,
99 Commercial Road,
Melbourne VIC 3004
Country 69538 0
Australia
Phone 69538 0
+61 (0)3 8532 1143
Fax 69538 0
+61 (0)3 8532 1899
Email 69538 0
[email protected]
Contact person for public queries
Name 69539 0
Miss Kristel Janssens
Address 69539 0
Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4, 99 Commercial Road, Melbourne VIC 3004
Country 69539 0
Australia
Phone 69539 0
+61 (0)3 8532 1169
Fax 69539 0
+61 (0)3 8532 1899
Email 69539 0
[email protected]
Contact person for scientific queries
Name 69540 0
A/Prof Andre La Gerche
Address 69540 0
Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4,
99 Commercial Road,
Melbourne VIC 3004
Country 69540 0
Australia
Phone 69540 0
+61 (0)3 8532 1143
Fax 69540 0
+61 (0)3 8532 1899
Email 69540 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIPersistent Impairment in Cardiopulmonary Fitness following Breast Cancer Chemotherapy2019https://doi.org/10.1249/mss.0000000000001970
N.B. These documents automatically identified may not have been verified by the study sponsor.