Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000464460
Ethics application status
Approved
Date submitted
5/09/2007
Date registered
13/09/2007
Date last updated
12/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy.
Scientific title
An observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer. 2333 0
Condition category
Condition code
Cancer 2435 2435 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational - rates of toxicity related treatment modification will be observed over four cycles of Adriamycin and Cyclophosphamide chemotherapy in three cohorts of patients - capped dose (body surface area >2m2), uncapped and obese (BSA < 2m2, body mass index >30), and uncapped and non-obese (BSA<2m2, BMI<30).
Intervention code [1] 2051 0
Not applicable
Comparator / control treatment
There is no comparator/control treatment/group as this is and Observational Study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3336 0
Rate of Treatment Modifying Toxicity.
Timepoint [1] 3336 0
Over four cycles of chemotherapy - any modification to treatment due to toxicity will be recorded at each treatment visit.
Secondary outcome [1] 5549 0
Nadir neutrophil count.
Timepoint [1] 5549 0
Post cycle one at Day 10.
Secondary outcome [2] 5550 0
Rate of grade 3 toxicities.
Timepoint [2] 5550 0
Over four cycles of chemotherapy - at each treatment visit.

Eligibility
Key inclusion criteria
Age = 18 years.
Female patients receiving Adriamycin (60mg/m2) and Cyclophosphamide (600mg/m2) chemotherapy for early breast cancer in the study institution(s).
Adequate pre-treatment bone marrow function defined as absolute neutrophil count = 1.5×106/L , platelet count = 100×109/L.
Calculated creatinine clearance by Cockroft-Gault or MDRD (Modification of Diet in Renal Disease) equation of = 60ml/min.
Ability to understand and the willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous exposure to cytotoxic agents or long-term immunosuppression.
Patient not willing to have chemotherapy at the study centre(s).
Known hypersensitivity to Adriamycin or Cyclophosphamide.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment outside Australia
Country [1] 598 0
New Zealand
State/province [1] 598 0

Funding & Sponsors
Funding source category [1] 2591 0
Charities/Societies/Foundations
Name [1] 2591 0
Wellington Cancer Society
Country [1] 2591 0
New Zealand
Primary sponsor type
Individual
Name
Dr Anne O'Donnell
Address
Wellington Blood and Cancer Centre
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country
New Zealand
Secondary sponsor category [1] 2344 0
Individual
Name [1] 2344 0
Dr Brendan Luey
Address [1] 2344 0
Wellington Blood and Cancer Centre
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country [1] 2344 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4512 0
Central Regional Ethics Committee
Ethics committee address [1] 4512 0
Ministry of Health
Level 2
1-3 The Terrace
Wellington
Ethics committee country [1] 4512 0
New Zealand
Date submitted for ethics approval [1] 4512 0
Approval date [1] 4512 0
15/06/2007
Ethics approval number [1] 4512 0

Summary
Brief summary
The purpose of this study is to help determine whether chemotherapy doses can be better adjusted for different body sizes and compositions. Chemotherapy doses are normally adjusted to match a patient’s size. There is concern It is thought that when dosing larger people in this way, they might experience more side effects from chemotherapy because of the bigger chemotherapy doses. Therefore many doctors around the world, including those at this institution, will keep chemotherapy doses below a certain maximum threshold. However some international studies have shown no increased side effects from giving larger people bigger doses of chemotherapy. This study will try to determine if there is any difference in side effects for patients of different body size when dosed in the usual manner with a maximum dose threshold in place.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28030 0
Address 28030 0
Country 28030 0
Phone 28030 0
Fax 28030 0
Email 28030 0
Contact person for public queries
Name 11187 0
Dr Anne O'Donnell
Address 11187 0
Wellington Blood and Cancer Centre
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country 11187 0
New Zealand
Phone 11187 0
+64 4 3855999
Fax 11187 0
Email 11187 0
anne.o'[email protected]
Contact person for scientific queries
Name 2115 0
Dr Anne O'Donnell
Address 2115 0
Wellington Blood and Cancer Centre
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country 2115 0
New Zealand
Phone 2115 0
+64 4 3855999
Fax 2115 0
Email 2115 0
anne.o'[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.