ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Not applicable

Comparator / control treatment

n/a

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

10 years from the time of recruitment

Secondary outcome [1]

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]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Hospital

Name [1]

Princess Alexandra Hospital

Address [1]

Ipswich Road
Woolongabba
Qld 4102

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Princess Alexandra Hospital Ethics commitee

Ethics committee address [1]

Ipswich Road
Woolongabba
Qld 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2010

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Mohamed Saleem

Address

level 4
School of medicine; Southside
Princess Alexandra Hospital
Qld 4102

Country

Australia

Phone

+61 7 31763066

Fax

+61 7 31763999

m.saleem@uq.edu.au

Contact person for scientific queries

Name

Mohamed Saleem

Address

level 4
School of medicine; Southside
Princess Alexandra Hospital
Qld 4102

Country

Australia

Phone

+61 7 31763066

Fax

+61 7 31763066

m.saleem@uq.edu.au

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.

Trial Review

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