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Trial registered on ANZCTR


Registration number
ACTRN12613000646741
Ethics application status
Approved
Date submitted
29/05/2013
Date registered
7/06/2013
Date last updated
24/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of corticosteroid and antihistamine premedication to prevent hypersensitivity reactions in patients receiving second (or subsequent) line treatment with Carboplatin for treatment of gynaecological malignancy
Scientific title
PREPaRE study. A pilot study of corticosteroid and antihistamine premedication to prevent hypersensitivity reactions in patients receiving second (or subsequent) line treatment with Carboplatin for treatment of gynaecological malignancy
Secondary ID [1] 282545 0
Nil
Universal Trial Number (UTN)
Trial acronym
PREPaRE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypersensitivity reactions in patients receiving carboplatin for gynaecological malignancy 289214 0
Condition category
Condition code
Cancer 289549 289549 0 0
Ovarian and primary peritoneal
Cancer 289588 289588 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be given the following premedication. The night before chemo (at least 12 hours prior to carboplatin): Dexamethasone 20mg orally, Loratadine 10mg orally and Ranitidine 150mg orally.
Morning of chemo (at least 2 hours prior to carboplatin):Dexamethasone 20mg orally, loratadine 10mg orally
In chemo suite (at least 30 mins prior to carboplatin): Dexamethasone 20mg intravenously, ranitidine 50mg intravenously, ondansetron 8mg intravenously (unless contraindicated)
Patients will be asked about adherence with the premedications on the patient questionnaire completed prior to all chemotherapy. All patients will be given the same premedication regime prior to all chemotherapy sessions.
Intervention code [1] 287215 0
Treatment: Drugs
Intervention code [2] 287273 0
Prevention
Comparator / control treatment
Outcomes will be compared with historical data from The Royal Women's Hospital Patients who received chemotherapy during 2010 and 2011. These patients received the following premedication on the morning of chemotherapy (at least 2 hours prior to carboplatin);

For carboplatin and paclitaxel regimen: Dexamethasone 20mg intravenously, loratadine 10mg orally, ranitidine 50mg intravenously, ondansetron 8mg intravenously (unless contraindicated)

For all other carboplatin containing regimens: dexamethasone 8mg intravenously, ondansetron 8mg intravenously (unless contraindicated)
Control group
Historical

Outcomes
Primary outcome [1] 289642 0
To document the incidence of carboplatin hypersensitivity reactions (HSR) in a population of patients receiving the defined premedication with second (or subsequent) line carboplatin for gynaecological malignancy. HSR will be documented using a HSR form where the investigator documents any symptoms occuring during or immediately after the carboplatin infusion and the patient records any symptoms occuring after discharge from the chemotherapy suite in a diary.
Timepoint [1] 289642 0
HSR symptoms will be recorded at the following time points for each cycle of chemotherapy with carboplatin:
1)Symptoms of acute HSR (i.e. HSR occurring during or immediately after carboplatin infusion)
2)Symptoms of delayed HSR (i.e. those occurring after discharge from chemotherapy suite)
Secondary outcome [1] 302927 0
To compare the incidence of carboplatin HSR in patients receiving routine premedication with a defined historical control. This will be meausred using clincial assessment
Timepoint [1] 302927 0
HSR symptoms will be collected by the Investigator and the patient using a diary during each cycle of chemotherapy and 28 days after chemotherapy with carboplatin.
Secondary outcome [2] 303004 0
To describe the nature and severity of carboplatin HSR symptoms (by CTC v4.0 classification) occuring in patients receiving the defined premedication
Timepoint [2] 303004 0
HSR symptoms will be collected by the Investigator and the patient using a diary during each cycle of chemotherapy and 28 days after chemotherapy with carboplatin.
Secondary outcome [3] 303005 0
To generate exploratory data on the relationship between clinical parameters (number of carboplatin cycles, co-administered chemotherapy agents, age, etc) and the incidence of carboplatin HSR, in order to make recommendation regarding stratification factors to be utilised in the randomised phase 2 eveluation of the premedication regimen (should this pilot justify progression to the second stage of evaluation). This will be measured using clincal assessment
Timepoint [3] 303005 0
end of the study

Eligibility
Key inclusion criteria
Age 18 years and above
Histologically confirmed gynaecological malignancy
Commencing a carboplatin-containing regimen (this may include other chemo agents)
At least 1 prior line of carboplatin containing therapy
Performance status less than or equal to 2
Neutrophil count greater than or equal to 1.5 x 109/L, Platelet count greater than or equal to 100 x 109/L
Ability to record symptoms in patient diary
Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of platinum HSR
Uncontrolled concurrent illness
Diabetes Mellitus requiring insulin
Pregnancy / lactation

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who are receiving second (or subsequent) line treatment with carboplatin for treatment of gynaecological malignancy who meet the eligability criteria will be informed of the study. Patients who wish to participate will be asked to provide written consent and all participants will be given the study premedication
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The incidence of carboplatin hypersensitivity reactions in this pilot trial will be compared to historical controls from the Royal Women's Hospital
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
N/A as pilot trial

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
30/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 1054 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 1055 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 6917 0
3052 - Parkville
Recruitment postcode(s) [2] 6918 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 287350 0
Hospital
Name [1] 287350 0
The Royal Women's Hospital
Country [1] 287350 0
Australia
Funding source category [2] 287351 0
Hospital
Name [2] 287351 0
Royal Prince Alfred Hospital
Country [2] 287351 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
Locked Bag 300
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 286098 0
None
Name [1] 286098 0
Address [1] 286098 0
Country [1] 286098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289326 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 289326 0
Locked Bag 300
Parkville VIC 3052
Ethics committee country [1] 289326 0
Australia
Date submitted for ethics approval [1] 289326 0
Approval date [1] 289326 0
29/10/2012
Ethics approval number [1] 289326 0
12/31

Summary
Brief summary
The study is evaluating whether premedication can prevent or delay the onset of carboplatin hypersensitivity reactions in women win gynaecological malignancy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a gynaecological malignancy, for which you will be commencing a carboplatin containing chemotherapy regime. Eligible patients will have already undergone at least one prior line of carboplatin containing therapy. Trial details All participants in this study will be given premedication with Dexamethasone, Loratadine and Ranitidine the night before chemotherapy, the morning of chemotherapy and about 30 minutes prior to chemotherapy. These will be administered orally (by mouth) the night before and the morning of chemotherapy, and intravenously (directly into the vein) about 30 minutes prior to chemotherapy. All participants will be asked to complete a symptom diary, and will be clinically assessed in order to evaluate whether the study premedication can prevent or delay the onset of hypersensitivity reactions following chemotherapy with carboplatin. If it does (compared to a control group who receive their care in the past), then a subsequent larger randomised trial will be developed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40250 0
Ms Huda Ismail
Address 40250 0
Pharmacy Department
The Royal Women's Hospital
Locked Bag 300
Parkville VIC 3052
Country 40250 0
Australia
Phone 40250 0
+61 3 8345 3194
Fax 40250 0
Email 40250 0
[email protected]
Contact person for public queries
Name 40251 0
Huda Ismail
Address 40251 0
Pharmacy Department
The Royal Women's Hospital
Locked Bag 300
Parkville VIC 3052
Country 40251 0
Australia
Phone 40251 0
+61 3 8345 3194
Fax 40251 0
Email 40251 0
[email protected]
Contact person for scientific queries
Name 40252 0
Sumitra Ananda
Address 40252 0
The Royal Women's Hospital
Locked Bag 300
Parkville VIC 3052
Country 40252 0
Australia
Phone 40252 0
+61 3 8345 2000
Fax 40252 0
Email 40252 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

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