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Effect of obesity and diabetes on treatment and outcomes in newly diagnosed breast cancer

A prospective study to investigate the total body exposure to chemetherapeutic drugs in node positive breast cancer patients classified by obesity and diabetes subgroups

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000196044
Acronym
None
Enrollment
128
Registered
2010-03-08
Start date
2010-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, dos

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

node positive breast cancer

Exclusion criteria

pregnancy, <18 years

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026