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Trial registered on ANZCTR


Registration number
ACTRN12609000463279
Ethics application status
Approved
Date submitted
4/06/2009
Date registered
16/06/2009
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the anti-sickness drug dexamethasone influence immune function in breast surgery?
Scientific title
The influence of antiemetic doses of dexamethasone on postoperative lymphocyte sub-populations after breast surgery
Secondary ID [1] 291660 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune function 236924 0
Condition category
Condition code
Anaesthesiology 237284 237284 0 0
Anaesthetics
Inflammatory and Immune System 237340 237340 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Granisetron 1mg, Dexamethasone 4mg or 8mg intravenously, single dose, after induction and immediately prior to surgery
Intervention code [1] 236714 0
Treatment: Drugs
Comparator / control treatment
Granisteron 1mg
Control group
Active

Outcomes
Primary outcome [1] 238095 0
Proportions of lymphocyte subpopulations on blood analysis
Timepoint [1] 238095 0
Baseline, 24 hours one week and six weeks after administration of drug
Secondary outcome [1] 242297 0
Serum Macrophage Inhibitory Factor concentrations
Timepoint [1] 242297 0
Baseline, 24 hours and 168 hours after administration of drug

Eligibility
Key inclusion criteria
Females undergoing breast surgery
American Society of Anesthesiologists (ASA) Class I-III
Minimum age
18 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current drug therapy with antiemetics, steroids or serotonergic antidepressants
Active infection
Known or suspected metastatic disease
Previous chemotherapy treatment
Patients receiving implants, such as mesh repairs
Allergy/intolerance to any of the study drugs (including renal or hepatic impairment, active peptic ulcer disease, ischaemic heart disease, QT prolongation, major psychiatric illness)
Diabetes mellitus or history of seizures
Participation in any other research trial
Pregnant or possibility of

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 237104 0
Hospital
Name [1] 237104 0
Royal Perth Hospital Research Department
Address [1] 237104 0
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847
Country [1] 237104 0
Australia
Primary sponsor type
Individual
Name
Clinical A/Professor Tomas Corcoran
Address
Department of Anaesthesia and Pain Medicine,
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847.
Country
Australia
Secondary sponsor category [1] 4605 0
Individual
Name [1] 4605 0
Dr Kirk Langley
Address [1] 4605 0
Department of Anaesthesia and Pain Medicine,
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847.
Country [1] 4605 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239199 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 239199 0
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847
Ethics committee country [1] 239199 0
Australia
Date submitted for ethics approval [1] 239199 0
05/11/2008
Approval date [1] 239199 0
05/12/2008
Ethics approval number [1] 239199 0
EC 2008/194

Summary
Brief summary
Dexamethasone is a drug commonly given to prevent postoperative nausea and vomiting. It also has properties that dampen the body's immune response to infection. In this study, we propose to examine female patients undergoing breast surgery. These patients are at high risk of nausea and vomiting and routinely receive drugs to prevent this. We will give patients one of two drugs, either dolasetron or dexamethasone when they are under anaesthetic. Blood samples will be taken before and after the drugs to determine the effect that they have on the immune system. We hope to determine whether dexathasone has an effect on the body's immune system.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29703 0
Prof Tomas Corcoran
Address 29703 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital
Country 29703 0
Australia
Phone 29703 0
+61414791151
Fax 29703 0
Email 29703 0
mascor@bigpond.net.au
Contact person for public queries
Name 12950 0
Prof Clinical A/Professor Tomas Corcoran
Address 12950 0
Department of Anaesthesia and Pain Medicine,
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847.
Country 12950 0
Australia
Phone 12950 0
+61 8 92241038
Fax 12950 0
+61 8 92241111
Email 12950 0
tomas.corcoran@health.wa.gov.au
Contact person for scientific queries
Name 3878 0
Prof Clinical A/Professor Tomas Corcoran
Address 3878 0
Department of Anaesthesia and Pain Medicine,
Royal Perth Hospital,
GPO Box X2213,
Perth,
W.A. 6847.
Country 3878 0
Australia
Phone 3878 0
+61 8 92241038
Fax 3878 0
+61 8 92241111
Email 3878 0
tomas.corcoran@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary