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
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
Date results information 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
Scientific title
A study to assess the incidence of tearing as a consequence of docetaxel chemotherapy in women with early breast cancer
Secondary ID [1] 253080 0
Epiphora
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epiphora 2887 0
Condition category
Condition code
Cancer 2362 2362 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 1982 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3261 0
To assess the frequency and severity of tearing in a group of consecutive patients receiving adjuvant docetaxel-based chemotherapy at 2 centres
Timepoint [1] 3261 0
Baseline, mid chemotherapy and 3 months after chemotherapy
Primary outcome [2] 3294 0
Incidence of epiphora
Timepoint [2] 3294 0
Baseline, after 3 cycles and at 12 weeks following chmoetherapy
Primary outcome [3] 3897 0
Proportion of patient who develop lacrimal duct stenosis
Timepoint [3] 3897 0
Before, during and after chemotherapy given
Secondary outcome [1] 5441 0
To assess the efficacy of a conservative approach versus surgical intervention in a subset of patients with documented lacrimal stenosis
Timepoint [1] 5441 0
Baseline, mid chemotherapy and 3 months after chemotherapy
Secondary outcome [2] 6569 0
Incidence of other eye pathology
Timepoint [2] 6569 0
Before, during and after chemotherapy given

Eligibility
Key inclusion criteria
Women with early breast cancer receiving docetaxel-based chemotherapy
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Tearing present prior to commencement of chemotherapy

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2008
Actual
30/11/2007
Date of last participant enrolment
Anticipated
Actual
1/06/2010
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
100
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5795 0
Mount Hospital - Perth

Funding & Sponsors
Funding source category [1] 2519 0
Commercial sector/Industry
Name [1] 2519 0
Sanofi Aventis
Country [1] 2519 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Aventis
Address
12-24 Talavera Road
Macquarie Park, NSW 2113
+61 (0)2 8666 2000
Country
Australia
Secondary sponsor category [1] 2282 0
None
Name [1] 2282 0
Address [1] 2282 0
Country [1] 2282 0
Other collaborator category [1] 11 0
Individual
Name [1] 11 0
Dr Richard De Boer
Address [1] 11 0
Western Hospital
Footscray
Victoria
Country [1] 11 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4432 0
Mount Hospital
Ethics committee address [1] 4432 0
150 Mounts Bay Rd
Perth 6000
WA
Ethics committee country [1] 4432 0
Australia
Date submitted for ethics approval [1] 4432 0
01/05/2007
Approval date [1] 4432 0
31/07/2007
Ethics approval number [1] 4432 0

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.
Trial website
Trial related presentations / publications
no publication was ever made for this trial
Public notes

Contacts
Principal investigator
Name 27990 0
Prof Arlene Chan
Address 27990 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 27990 0
Australia
Phone 27990 0
+ 08 6500 5555
Fax 27990 0
Email 27990 0
[email protected]
Contact person for public queries
Name 11147 0
Mrs Jeannette Devoto
Address 11147 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 11147 0
Australia
Phone 11147 0
+61 8 6500 5555
Fax 11147 0
Email 11147 0
[email protected]
Contact person for scientific queries
Name 2075 0
Prof Dr Arlene Chan
Address 2075 0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country 2075 0
Australia
Phone 2075 0
618-94814522
Fax 2075 0
Email 2075 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.