Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000196044
Ethics application status
Not yet submitted
Date submitted
5/03/2010
Date registered
8/03/2010
Date last updated
8/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of obesity and diabetes on treatment and outcomes in newly diagnosed breast cancer
Scientific title
A prospective study to investigate the total body exposure to chemetherapeutic drugs in node positive breast cancer patients classified by obesity and diabetes subgroups
Secondary ID [1] 1465 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer chemotherapy dosing 256914 0
Condition category
Condition code
Cancer 257062 257062 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A 1 year prospective study of node positive breast cancer patients presenting to the Princess Alexandra Hospital will be undertaken to examine total body exposure of chemotherapy drugs. Baseline data on obesity , diabetes and other factors that may influence drug exposure including weight and height at diagnosis; basic biochemistry including glucose, diabetes diagnosis and control; stage of disease; co-morbidities (such as renal impairment); use of hormone replacement therapy, medications, dose and type of chemotherapy will be collected. Total body exposure for the various chemotherapeutic agents used will be calculated by measuring serum drug levels at various points in time points ( 0 hrs,1 hr, 2hrs, 4hrs and 8 hours) during administration of these drugs during the first cylcle of chemotherapy.
Results: The total body exposure will be analysed to see if their is a statistical difference in the different obesity and diabetes groupings. We will look at both the relative under-dosing in obese women with breast cancer, and the combined effect of diabetes and obesity on other known risk factors for breast cancer. Ultimately if it can be clearly shown that obesity results in less than optimal chemotherapy treatment and may result in reduced survival, then treatment of obesity and good diabetes control may become an even more important facet of breast cancer management. This is particularly pertinent given our epidemic of obesity and of diabetes.
Intervention code [1] 256110 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257952 0
Establishing whether adequate total body exposure to the chemotherapeuting agent has been achieved inthe various subgroups by calculated area under the curve for chemotherapy drugs
Timepoint [1] 257952 0
1 year from the start of the study. This is expected to be the time period to recruit ther equired number of participants
Primary outcome [2] 257953 0
survival will be done as part of another study 10 years down the track by linking these patients with the National cancer registry
Timepoint [2] 257953 0
10 years from the time of recruitment
Secondary outcome [1] 263480 0
mortality will be done as part of another study 10 years down the track by linking these patients with the National cancer registry
Timepoint [1] 263480 0
10 year from the time of recruitment

Eligibility
Key inclusion criteria
node positive breast cancer
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, <18 years

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256605 0
Self funded/Unfunded
Name [1] 256605 0
Country [1] 256605 0
Primary sponsor type
University
Name
University of Queensland
Address
Level 4 ;School of medicine
Princess Alexandra Hospital
qld 4102
Country
Australia
Secondary sponsor category [1] 255897 0
Hospital
Name [1] 255897 0
Princess Alexandra Hospital
Address [1] 255897 0
Ipswich Road
Woolongabba
Qld 4102
Country [1] 255897 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258633 0
Princess Alexandra Hospital Ethics commitee
Ethics committee address [1] 258633 0
Ipswich Road
Woolongabba
Qld 4102
Ethics committee country [1] 258633 0
Australia
Date submitted for ethics approval [1] 258633 0
15/03/2010
Approval date [1] 258633 0
Ethics approval number [1] 258633 0

Summary
Brief summary
Background: Obesity, type 2 diabetes and breast cancer are common diseases. Each of these alone are major health care problems in developed countries such as Australia. As more people acquire these diseases as they get older and as life expectancy increases, the health care costs of these will increase exponentially.
Both obesity and diabetes, on its own can cause cancer. A recent study from Queensland and one other reviewing all of the data on this area suggested that both diabetes and obesity can increase death from breast cancer. There is a suggestion that some of this increased death rate may be because obese people and those with diabetes have other medical problems which may lead to reduced dose of chemotherapy being given. For these reasons it is a developing yet urgent area of research interest for patients, clinicians, Governments and policy makers.

Aims: To Examine
1) whether obese women with breast cancer are more or less likely to be dosed with appropriate doses of chemotherapy
2) Whether there is a difference in total body exposure for the various chemotherapeutic agents utilised amongst the subgroups classified by obesity and diabetes.
Method:
A 1 year prospective study of node positive breast cancer patients presenting to the Princess Alexandra Hospital (PAH) will be undertaken to examine total body exposure of chemotherapy drugs. Baseline data on obesity , diabetes and other factors that may influence drug exposure including weight and height at diagnosis; basic biochemistry including glucose, diabetes diagnosis and control; stage of disease; co-morbidities (such as renal impairment); use of hormone replacement therapy, medications, dose and type of chemotherapy will be collected. Total body exposure for the various chemotherapeutic agents used will be calculated by measuring serum drug levels at various points in time points ( 0 hrs,1 hr, 2hrs, 4hrs and 8 hours) during administration of these drugs during the first cylcle of chemotherapy.
Results: The total body exposure will be analysed to see if their is a statistical difference in the different obesity and diabetes groupings. We will look at both the relative under-dosing in obese women with breast cancer, and the combined effect of diabetes and obesity on other known risk factors for breast cancer. Ultimately if it can be clearly shown that obesity results in less than optimal chemotherapy treatment and may result in reduced survival, then treatment of obesity and good diabetes control may become an even more important facet of breast cancer management. This is particularly pertinent given our epidemic of obesity and of diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30901 0
Address 30901 0
Country 30901 0
Phone 30901 0
Fax 30901 0
Email 30901 0
Contact person for public queries
Name 14148 0
Mohamed Saleem
Address 14148 0
level 4
School of medicine; Southside
Princess Alexandra Hospital
Qld 4102
Country 14148 0
Australia
Phone 14148 0
+61 7 31763066
Fax 14148 0
+61 7 31763999
Email 14148 0
[email protected]
Contact person for scientific queries
Name 5076 0
Mohamed Saleem
Address 5076 0
level 4
School of medicine; Southside
Princess Alexandra Hospital
Qld 4102
Country 5076 0
Australia
Phone 5076 0
+61 7 31763066
Fax 5076 0
+61 7 31763066
Email 5076 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
No additional documents have been identified.