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Trial registered on ANZCTR
Registration number
ACTRN12608000111370
Ethics application status
Approved
Date submitted
16/08/2007
Date registered
28/02/2008
Date last updated
8/04/2021
Date data sharing statement initially provided
8/04/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Prevalence of epiphora in women with early breast cancer receiving adjuvant docetaxel-based chemotherapy
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Scientific title
A study to assess the incidence of tearing as a consequence of docetaxel chemotherapy in women with early breast cancer
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Secondary ID [1]
253080
0
Epiphora
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epiphora
2887
0
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Condition category
Condition code
Cancer
2362
2362
0
0
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
To measure the incidence of tearing by symptom review. clinical examination and Computerised tomography Dacrocystogram from baseline to 3 months following completion of chemotherapy
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Intervention code [1]
1982
0
Not applicable
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
3261
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To assess the frequency and severity of tearing in a group of consecutive patients receiving adjuvant docetaxel-based chemotherapy at 2 centres
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Assessment method [1]
3261
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Timepoint [1]
3261
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Baseline, mid chemotherapy and 3 months after chemotherapy
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Primary outcome [2]
3294
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Incidence of epiphora
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Assessment method [2]
3294
0
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Timepoint [2]
3294
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Baseline, after 3 cycles and at 12 weeks following chmoetherapy
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Primary outcome [3]
3897
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Proportion of patient who develop lacrimal duct stenosis
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Assessment method [3]
3897
0
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Timepoint [3]
3897
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Before, during and after chemotherapy given
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Secondary outcome [1]
5441
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To assess the efficacy of a conservative approach versus surgical intervention in a subset of patients with documented lacrimal stenosis
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Assessment method [1]
5441
0
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Timepoint [1]
5441
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Baseline, mid chemotherapy and 3 months after chemotherapy
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Secondary outcome [2]
6569
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Incidence of other eye pathology
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Assessment method [2]
6569
0
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Timepoint [2]
6569
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Before, during and after chemotherapy given
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Eligibility
Key inclusion criteria
Women with early breast cancer receiving docetaxel-based chemotherapy
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Tearing present prior to commencement of chemotherapy
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2008
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Actual
30/11/2007
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Date of last participant enrolment
Anticipated
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Actual
1/06/2010
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
100
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Accrual to date
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Final
85
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
5795
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Mount Hospital - Perth
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Funding & Sponsors
Funding source category [1]
2519
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Commercial sector/Industry
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Name [1]
2519
0
Sanofi Aventis
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Address [1]
2519
0
sanofi-aventis
Talavera Corporate Centre
Building D
12-24 Talavera Road
Macquarie Park, NSW 2113
+61 (0)2 8666 2000
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Country [1]
2519
0
Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Sanofi Aventis
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Address
12-24 Talavera Road
Macquarie Park, NSW 2113
+61 (0)2 8666 2000
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Country
Australia
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Secondary sponsor category [1]
2282
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None
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Name [1]
2282
0
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Address [1]
2282
0
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Country [1]
2282
0
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Other collaborator category [1]
11
0
Individual
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Name [1]
11
0
Dr Richard De Boer
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Address [1]
11
0
Western Hospital
Footscray
Victoria
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Country [1]
11
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
4432
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Mount Hospital
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Ethics committee address [1]
4432
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150 Mounts Bay Rd Perth 6000 WA
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Ethics committee country [1]
4432
0
Australia
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Date submitted for ethics approval [1]
4432
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01/05/2007
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Approval date [1]
4432
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31/07/2007
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Ethics approval number [1]
4432
0
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Summary
Brief summary
This study will monitor whether you develop tearing and if so, how frequent and severe this complaint is. It will involve assessment of theeyes before start chemotherapy, during and at the end of treatment.
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Trial website
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Trial related presentations / publications
no publication was ever made for this trial
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Public notes
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Contacts
Principal investigator
Name
27990
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Prof Arlene Chan
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Address
27990
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Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
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Country
27990
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Australia
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Phone
27990
0
+ 08 6500 5555
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Fax
27990
0
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Email
27990
0
[email protected]
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Contact person for public queries
Name
11147
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Jeannette Devoto
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Address
11147
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Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
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Country
11147
0
Australia
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Phone
11147
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+61 8 6500 5555
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Fax
11147
0
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Email
11147
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[email protected]
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Contact person for scientific queries
Name
2075
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Dr Arlene Chan
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Address
2075
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Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
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Country
2075
0
Australia
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Phone
2075
0
618-94814522
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Fax
2075
0
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Email
2075
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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