Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000477224
Ethics application status
Approved
Date submitted
8/06/2009
Date registered
17/06/2009
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Observational Study Reviewing the Incidence of Nail Changes in Patients Receiving Docetaxel- Based Chemotherapy
Scientific title
A Prospective Observational Study Reviewing the Incidence of Nail Changes in Breast Cancer Patients Receiving Docetaxel- Based Chemotherapy
Secondary ID [1] 253064 0
Nail study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous toxicity 236945 0
Breast cancer 237036 0
Condition category
Condition code
Cancer 237296 237296 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of nail changes in patients receiving docetaxel based chemotherapy over approx. 6 months.
Dose, mode of administration and frequency of treatment with docetaxel are dependent upon the docetaxel chemotherapy regimen chosen. This will be at the discretion of the clinician and details will be recorded for each treatment cycle .
Intervention code [1] 236715 0
Not applicable
Comparator / control treatment
Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238106 0
Assess frequency and severity of nail changes in women with early breast cancer receiving docetaxel based chemotherapy, using patient observation,clinician assessment and photographs.
Timepoint [1] 238106 0
Outcome measured at baseline,on day 1 of each chemotherapy cycle and at each follow-up visit until trial conclusion estimated to be 2011
Primary outcome [2] 238107 0
Assess impact of nail changes functionally and cosmetically,using patient self reports and questionaires.
Timepoint [2] 238107 0
Outcome measured at baseline,on day 1 of each chemotherapy cycle and at each follow-up visit until trial conclusion estimated to be 2011
Secondary outcome [1] 242318 0
Describe current treatment practices for management of nail changes in Australia,using patient interviews and questionaires.
Timepoint [1] 242318 0
Outcome measured at baseline,on day 1 of each chemotherapy cycle and at each follow-up visit until trial conclusion estimated to be 2011.

Eligibility
Key inclusion criteria
Women with early breast cancer receiving adjuvent docetaxel based chemotherapy for at least 3 cycles of chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious intercurrent illness or psychological,sociological, geographical conditions which would preclude adequate follow up and compliance with the protocol.
Pre-existing nail conditions.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
5/06/2009
Actual
5/06/2009
Date of last participant enrolment
Anticipated
Actual
27/07/2010
Date of last data collection
Anticipated
27/07/2010
Actual
27/07/2010
Sample size
Target
150
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5802 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 13244 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 237123 0
Commercial sector/Industry
Name [1] 237123 0
Sanofi Aventis
Country [1] 237123 0
Australia
Primary sponsor type
Individual
Name
Dr Arlene Chan
Address
Mount Clinical Trials
Suite 22, Level 2
146 Mounts Bay Rd
Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 4616 0
None
Name [1] 4616 0
Address [1] 4616 0
Country [1] 4616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239223 0
Mount Hospital Ethics Comittee
Ethics committee address [1] 239223 0
150 Mounts Bay Rd
Perth,
WA 6000
Ethics committee country [1] 239223 0
Australia
Date submitted for ethics approval [1] 239223 0
Approval date [1] 239223 0
05/02/2008
Ethics approval number [1] 239223 0
E.C. 44.7

Summary
Brief summary
assessment of nail changes to patients undergoing chemotherapy with taxotere. Nail bed toxicity was assessed by physical examination, questionnaire completion and photographs. Study participation during chemotherapy treatment and up to 3 months post chemotherapy.
Trial website
Trial related presentations / publications
no publication or analysis was done on this trial
Public notes

Contacts
Principal investigator
Name 29704 0
Prof Arlene Chan
Address 29704 0
Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA
Country 29704 0
Australia
Phone 29704 0
+ 61 8 6500 5555
Fax 29704 0
Email 29704 0
[email protected]
Contact person for public queries
Name 12951 0
Mrs Jeannette Devoto
Address 12951 0
Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA
Country 12951 0
Australia
Phone 12951 0
+ 61 8 6500 5555
Fax 12951 0
Email 12951 0
[email protected]
Contact person for scientific queries
Name 3879 0
Mrs Jeannette Devoto
Address 3879 0
Breast Cancer Research Centre,-WA, Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands, 6009 WA
Country 3879 0
Australia
Phone 3879 0
+61 8 6500 5555
Fax 3879 0
Email 3879 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.