ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast cancer

Peripheral neuropathy

Condition category

Condition code

Cancer

Breast

Cancer

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]

Early Detection / Screening

Comparator / control treatment

Standard physician-based assessment (patients are their own control)

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Percentage of neuropathy interfering with instrumental ADLs , as recorded by CIPN15 (abbreviated form of CIPN20) and CTCAE grading

Timepoint [1]

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]

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]

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?

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

1 Port Road
Adelaide 5000 SA

Country [1]

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]

None

Name [1]

None

Address [1]

Not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics committee

Ethics committee address [1]

Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2018

Approval date [1]

25/06/2018

Ethics approval number [1]

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

A/Prof Nick Murray

Address

Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA

Country

Australia

Phone

0061 08 70740000

Fax

nick.murray@sa.gov.au

Contact person for public queries

Name

Nikki Burdett

Address

Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA

Country

Australia

Phone

0061 08 70740000

Fax

nikki.burdett@sa.gov.au

Contact person for scientific queries

Name

Nikki Burdett

Address

Medical Oncology department
Royal Adelaide Hospital
1 Port Road Adelaide
5000 SA

Country

Australia

Phone

0061 08 70740000

Fax

nikki.burdett@sa.gov.au

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.

Trial Review

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