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Trial registered on ANZCTR


Registration number
ACTRN12614001055695
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
3/10/2014
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study of the effect of chemotherapy on metabolic and cardiovascular function in women with early stage breast cancer
Scientific title
A prospective study of the effect of chemotherapy on metabolic and cardiovascular function in women with early stage breast cancer
Secondary ID [1] 285162 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early stage breast cancer 292753 0
Condition category
Condition code
Cancer 293044 293044 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer. This will be assessed by conducting the following procedures at 3 different time points over 9 months - pre-chemotherapy (baseline), midway through chemotherapy and end of treatment
Interviews
Cardiovascular investigations
Metabolic investigations
Intervention code [1] 290016 0
Not applicable
Comparator / control treatment
The control group will be be healthy volunteers who will be assessed by conducting the following procedures once Interviews
Cardiovascular investigations
Metabolic investigations
Control group
Active

Outcomes
Primary outcome [1] 292917 0
The primary endpoint is the change in pulse wave velocity from baseline test to post chemotherapy testing.
Pulse wave velocity (PWV)
PWV will also be performed to quantify arterial stiffness. A Sphygmocor device and electrocardiography will be used to measure the velocity of pressure waves at the carotid and femoral arteries.
It will take approximately 30 minutes to perform PWA and PWV testing.
Timepoint [1] 292917 0
Nine months.
Secondary outcome [1] 309930 0
Changes in established markers of cardiovascular function.

Established markers of cardiovascular function
a. arterial stiffness using pulse wave analysis and pulse wave velocity
b. sympathetic nervous system function using spontaneous baroreceptor activity
c. endothelial function using finger arterial pulsatile volume changes
d. inflammation using blood markers, including C-Reactive Protein (CRP) and interleukins using measurements of levels in the serum
Timepoint [1] 309930 0
9 months
Secondary outcome [2] 309931 0
Changes in markers of energy balance.

markers of energy balance
a. caloric intake using multiple pass recall methodology
b. resting energy expenditure using indirect calorimetry
c. diet-induced thermogenesis using indirect calorimetry
d. physical exercise using the International Physical Activity Questionnaire
Timepoint [2] 309931 0
9 months

Eligibility
Key inclusion criteria
1. Female with histologically proven invasive breast cancer
2. American Joint Committee on Cancer (AJCC) Tumour Node Metastasis (TNM) Stage I - III disease
3. Age equal to or greater than 18 years
4. To commence adjuvant chemotherapy for breast cancer
5. ECOG Performance Status 0-2

Inclusion criteria for age and gender matched controls
1. Female
2. Age within 5 years of matched patient’s age
3. No current or previous diagnosis of cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current use of insulin or oral hypoglycaemic agents
2. Current use of beta blockers
3. Current use of antiplatelets/anticoagulants including aspirin, clopidogrel, warfarin, heparin
4. Presence of atrial fibrillation
5. Diagnosis of Raynaud’s syndrome
6. History of claustrophobia
7. Medical or psychiatric condition that compromises the subject’s ability to give informed consent
8. Difficult venous access
9. Large chest wall seroma

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2014
Actual
11/08/2014
Date of last participant enrolment
Anticipated
Actual
28/02/2018
Date of last data collection
Anticipated
Actual
13/08/2019
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289775 0
Self funded/Unfunded
Name [1] 289775 0
Country [1] 289775 0
Primary sponsor type
Individual
Name
A/Prof Bogda Koczwara
Address
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 288464 0
None
Name [1] 288464 0
Address [1] 288464 0
Country [1] 288464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304084 0
SACHREC
Ethics committee address [1] 304084 0
Flinders Medical Centre
Flinders Drive
Bedford park
SA 5042
Ethics committee country [1] 304084 0
Australia
Date submitted for ethics approval [1] 304084 0
Approval date [1] 304084 0
05/05/2014
Ethics approval number [1] 304084 0

Summary
Brief summary
This study will investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer.

Who is it for?
You may be eligible to join this study if you are a female aged at least 18 years who has been diagnosed with early stage breast cancer, for which you are due to commence chemotherapy. Healthy age and gender matched control patients will also be recruited to provide a benchmark for comparison.

Study details
All participants in this study will undergo interviews, questionniares, cardiovascular investigations, and metabolic investigations. This will involve insertion of intravenous cannulas (i.e. into the vein), so that blood samples can be taken. Breast cancer patients will be assessed at 3 timepoints over 9 months, i.e. at baseline (just prior to first chemotherapy) 3 months and then 9 months later. Healthy volunteers will be assessed on a single occasion only.
The following assessments will take place at each visit;

Study procedures: Participant presents after overnight fast. The visit will take about 5-6 hours.

General Assessment: Measuring weight, height, waist and hip circumference, heart rate, blood pressure and temperature will be recorded.

Assessment of cardiovascular risk: Measurement of arterial stiffness: assessed by measuring the pressure wave the heart produces in arteries with a small blunt probe. Assessment is not painful and usually takes about 30 minutes to complete. Measurement of autonomic nervous system activity: measured non-invasively: small changes in heart rate and blood pressure will be measured. Urine test: the specimen will then be sent to the lab to be tested for the amount of some chemicals which help measure the activity of the sympathetic nervous system. Measurement of endothelial function: measured by placing a probe on one finger of each hand to record pulsation of the arteries in the finger. By measuring the change in blood vessels after a blood pressure cuff on the arm is inflated and then deflated.

Blood tests: A needle will be inserted into a vein in one arm, with a small plastic tube (drip) left in from which we will take blood samples. A baseline blood sample will be taken from you. You will then be asked to eat a meal over 15 minutes; then a series of blood samples will be collected from intravenous catheter over the two hours following the meal. In all, about 75mL of blood (less than one sixth of a blood donation) will be collected as part of this test. The results from these blood tests will tell us how much insulin the body makes in response to the meal. Additional blood samples: When we take the first blood sample before the meal we will also take an additional sample. This could be used to measure the cholesterol and other markers of cardiovascular risk that show up in your blood.

Assessment of energy intake and expenditure: Estimating Energy intake: through an interview by on the doctors or nurses involved in the study, and asking to tell us what you have eaten over the last 24 hours. (10 to 15 minutes.) Physical activity: We will ask you to complete a questionnaire to tell us of your physical activity levels over the last 7 days. (10 to 15 minutes) Indirect calorimetry: measures the rate of energy expenditure before and after the meal. A clear plastic hood will be placed over the head for 20 minutes. You can breathe normally while under the hood and it does not restrict the amount of oxygen you inhale. The hood is connected to a machine that measures the energy expenditure Measurement of brown fat activity: by taking a picture with a special infrared camera before and after the meal that measures the temperature in the supraclavicular fossa (lower neck) very accurately.

Measurement of body composition using a DEXA machine (the same machine that is used to measure bone density). You will be asked to lie on a bed while a scanner takes a picture of you. The scan is painless and takes about 10 minutes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50674 0
Prof Bogda Koczwara
Address 50674 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50674 0
Australia
Phone 50674 0
+61 8 8204 8997
Fax 50674 0
Email 50674 0
[email protected]
Contact person for public queries
Name 50675 0
Kelly Mead
Address 50675 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50675 0
Australia
Phone 50675 0
+61 8 82046151
Fax 50675 0
Email 50675 0
[email protected]
Contact person for scientific queries
Name 50676 0
Kelly Mead
Address 50676 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50676 0
Australia
Phone 50676 0
+61 8 82046151
Fax 50676 0
Email 50676 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
not planned


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
EmbaseInsulin sensitivity, cardiovascular function and bone health in women with early stage breast cancer before and after cancer treatment.2022https://dx.doi.org/10.1111/imj.15469
N.B. These documents automatically identified may not have been verified by the study sponsor.