ANZCTR - Registration

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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

Date results information 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Early stage breast cancer

Condition category

Condition code

Cancer

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]

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]

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]

Nine months.

Secondary outcome [1]

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]

9 months

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SACHREC

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford park
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/05/2014

Ethics approval number [1]

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

Prof Bogda Koczwara

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 8204 8997

Fax

[email protected]

Contact person for public queries

Name

Miss Kelly Mead

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82046151

Fax

[email protected]

Contact person for scientific queries

Name

Miss Kelly Mead

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82046151

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Insulin sensitivity, cardiovascular function and bone health in women with early stage breast cancer before and after cancer treatment.	2022	https://dx.doi.org/10.1111/imj.15469

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically