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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
Patient registry
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
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

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

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
Can healthy volunteers participate?
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
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 289775 0
Self funded/Unfunded
Name [1] 289775 0
Address [1] 289775 0
Country [1] 289775 0
Primary sponsor type
A/Prof Bogda Koczwara
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Secondary sponsor category [1] 288464 0
Name [1] 288464 0
Address [1] 288464 0
Country [1] 288464 0

Ethics approval
Ethics application status

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

Principal investigator
Name 50674 0
Prof Bogda Koczwara
Address 50674 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50674 0
Phone 50674 0
+61 8 8204 8997
Fax 50674 0
Email 50674 0
Contact person for public queries
Name 50675 0
Miss Kelly Mead
Address 50675 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50675 0
Phone 50675 0
+61 8 82046151
Fax 50675 0
Email 50675 0
Contact person for scientific queries
Name 50676 0
Miss Kelly Mead
Address 50676 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 50676 0
Phone 50676 0
+61 8 82046151
Fax 50676 0
Email 50676 0

No data has been provided for results reporting
Summary results
Not applicable