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Trial registered on ANZCTR


Registration number
ACTRN12618001378213
Ethics application status
Approved
Date submitted
10/08/2018
Date registered
16/08/2018
Date last updated
16/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of taxane-induced neuropathy using patient-reported outcomes
Scientific title
Detection of taxane-induced neuropathy using patient-reported outcomes
Secondary ID [1] 295782 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 309211 0
Peripheral neuropathy 309212 0
Condition category
Condition code
Cancer 308104 308104 0 0
Breast
Cancer 308105 308105 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with breast cancer who are receiving neoadjuvant or adjuvant chemotherapy which includes weekly paclitaxel may be eligible. Eligible patients will have enrolment discussed by their Oncology team.
Details of pre-existing comorbidities and neuropathy will be collected for all consenting patients
Patients will complete the EORTC QLQ CIPN20 questionnaire on cycle 1 day 1 of chemotherapy, then at the end of 3, 6, 9, 12 weeks
Intervention code [1] 312119 0
Early Detection / Screening
Comparator / control treatment
Standard physician-based assessment (patients are their own control)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307068 0
Percentage of neuropathy interfering with instrumental ADLs , as recorded by CIPN15 (abbreviated form of CIPN20) and CTCAE grading
Timepoint [1] 307068 0
EORTC QLQ CIPN20 completed on cycle 1 day 1, then at the completion of 3, 6, 9 and 12 weeks of paclitaxel
Secondary outcome [1] 350538 0
Percentage of neuropathy interfering with personal ADLs, as recorded by CIPN15 (abbreviated form of CIPN20) and CTCAE grading

Dose modifications or alterations to regimen for neuropathy
Timepoint [1] 350538 0
EORTC QLQ CIPN20 completed on cycle 1 day 1, then at the completion of 3, 6, 9 and 12 weeks of paclitaxel

Eligibility
Key inclusion criteria
Patients receiving adjuvant or neoadjuvant weekly paclitaxel (80mg/m²) for the treatment of breast cancer; may be in combination with trastuzumab for HER2+ve patients
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unable to complete CIPN20 in English

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used.
Endpoint include:
Percentage of neuropathy interfering with instrumental ADLs , as recorded by CIPN15 versus standard CTCAE-based clinician reporting
Percentage of neuropathy interfering with personal ADLs, as recorded by CIPN15 versus standard CTCAE-based clinician reporting
Dose modifications or alterations to regimen for neuropathy

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11638 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 23684 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 300372 0
Hospital
Name [1] 300372 0
Royal Adelaide Hospital
Country [1] 300372 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital
Medical Oncology department
1 Port Rd Adelaide
5000 SA
Country
Australia
Secondary sponsor category [1] 299823 0
None
Name [1] 299823 0
None
Address [1] 299823 0
Not applicable
Country [1] 299823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301184 0
Central Adelaide Local Health Network Human Research Ethics committee
Ethics committee address [1] 301184 0
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA
Ethics committee country [1] 301184 0
Australia
Date submitted for ethics approval [1] 301184 0
28/03/2018
Approval date [1] 301184 0
25/06/2018
Ethics approval number [1] 301184 0
HREC/18/CALHN/349

Summary
Brief summary
Many women receive chemotherapy to decrease the chance of breast cancer recurrence after surgery. These drugs include chemotherapy which is collectively termed taxane-based chemotherapy. Though this is effective in decreasing recurrence, it may cause adverse effects which include peripheral neuropathy, or damage to the nerves, particularly in the hands and feet. This nerve damage can be disabling, causing difficulty in work-related tasking such as typing on a keyboard, difficulty holding objects or fastening buttons. If severe, it can impair the ability to drive or cause falls.

We hope to test a better way of detecting peripheral neuropathy than our current grading system, so that early symptoms can be identified and treatment changed to prevent this.

Who is it for?
You may be eligible for this study if you have a diagnosis of breast cancer and your oncologist plans to use weekly paclitaxel in your treatment plan.

Study details
If you participate, you will complete a form with details of pre-existing health problems and symptoms of neuropathy
You will complete the neuropathy symptom tool (EORTC QLQ CIPN20) on cycle 1 day 1 of chemotherapy, then at 3, 6, 9, 12 weeks into your treatment

There will be no additional visits. Your oncologist will not see the results of these questionnaires so if you have symptoms you should also discuss these with your oncologist in your clinic appointment.

It is hoped this research will demonstrate that EORTC QLQ CIPN20 is more sensitive than standard practice, and could be used to identify neuropathy earlier that would allow modifications to treatment to be made before more severe symptoms develop.
Trial website
Not applicable
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 86138 0
A/Prof Nick Murray
Address 86138 0
Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA
Country 86138 0
Australia
Phone 86138 0
0061 08 70740000
Fax 86138 0
Email 86138 0
[email protected]
Contact person for public queries
Name 86139 0
Nikki Burdett
Address 86139 0
Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA
Country 86139 0
Australia
Phone 86139 0
0061 08 70740000
Fax 86139 0
Email 86139 0
[email protected]
Contact person for scientific queries
Name 86140 0
Nikki Burdett
Address 86140 0
Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA
Country 86140 0
Australia
Phone 86140 0
0061 08 70740000
Fax 86140 0
Email 86140 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.