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Trial registered on ANZCTR


Registration number
ACTRN12615000921583
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
3/09/2015
Date last updated
25/03/2022
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Neurotoxic Potential of Abraxane versus Oxaliplatin and Paclitaxel
Scientific title
Comparison of Neurotoxic Potential of Abraxane versus Oxaliplatin and Paclitaxel chemotherapy in cancer patients
Secondary ID [1] 287120 0
nil
Universal Trial Number (UTN)
U1111-1172-3671
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy- induced peripheral neuropathy 295651 0
Pancreatic cancer 295791 0
Breast cancer 295792 0
Non-small cell lung cancer
 295793 0
Ovarian cancer 295794 0
Colorectal cancer 295796 0
Condition category
Condition code
Neurological 295931 295931 0 0
Other neurological disorders
Cancer 295932 295932 0 0
Pancreatic
Cancer 296061 296061 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 receiving abraxane chemotherapy for pancreatic cancer, breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer will be recruited into the study to document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. Examples of neurotoxicity seen with abraxane therapy include sensory dysasthesia including numbness and tingling in the hands and feet.

Patients will be assessed monthly from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment, to a maximum period of 2 years following enrolment.
Intervention code [1] 292368 0
Not applicable
Comparator / control treatment
Patients receiving paclitaxel or oxaliplatin chemotherapy will be recruited for comparative neurophysiological testing.
Control group
Active

Outcomes
Primary outcome [1] 295654 0
To document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment.

The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.
Timepoint [1] 295654 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [1] 316115 0
Nerve conduction measures (sural sensory amplitude) testing bilateral sural nerve conduction.
Timepoint [1] 316115 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [2] 316140 0
Non-invasive threshold tracking of the median nerve; sensory and motor peripheral nerve excitability (composite score; threshold electrotonus, refractoriness, superexcitability).
Timepoint [2] 316140 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [3] 316142 0
Nine-hole page test: measuring upper limb dexterity
Timepoint [3] 316142 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [4] 316143 0
FACT questionnaire (FACT-GOG-NTX 13 and FACT-TAXANE: a validated questionnaire relating to neuropathy-quality of life
Timepoint [4] 316143 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [5] 316148 0
Handgrip strength: assessed using a Handgrip dynamometer
Timepoint [5] 316148 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [6] 316149 0
Walking speed- timed 25 foot walk test; assessment of lower limb functional impairment
Timepoint [6] 316149 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.
Secondary outcome [7] 316150 0
Berg Balance Scale: to determine ability to safely balance during a series of predetermined tasks
Timepoint [7] 316150 0
Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.

Eligibility
Key inclusion criteria
1. Receiving Abraxane chemotherapy, oxaliplatin chemotherapy or paclitaxel chemotherapy at designated study sites.
2. 18-75 years of age.
3. Able to provide written informed consent.
4. For Abraxane-treated patients, histological or cytological confirmation of breast, non-small cell lung, ovarian or pancreatic cancer
5. For paclitaxel and oxaliplatin- treated patients, histological or cytological confirmation of breast, ovarian, pancreatic or colorectal cancer.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical symptoms of pre-existing neuropathy.
2. Concurrent use of other neuromodulating agents (e.g. carbamazepine, topiramate, phenytoin), which may confound interpretation of excitability data.
3. Significant neurological or psychiatric disorders.

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
1/10/2015
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
20/02/2020
Date of last data collection
Anticipated
Actual
3/09/2020
Sample size
Target
90
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 291709 0
Commercial sector/Industry
Name [1] 291709 0
Celgene Corporation
Country [1] 291709 0
United States of America
Primary sponsor type
Government body
Name
South Eastern Local Health Network
Address
Prince of Wales Hospital, Barker St, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 290384 0
University
Name [1] 290384 0
University of New South Wales
Address [1] 290384 0
Gate 9, High St
Kensington NSW 2052
Country [1] 290384 0
Australia
Other collaborator category [1] 278542 0
Individual
Name [1] 278542 0
Prof David Goldstein
Address [1] 278542 0
Department of Medical Oncology
Prince of Wales Hospital
Barker St
Randwick, NSW, 2031
Country [1] 278542 0
Australia
Other collaborator category [2] 278543 0
Individual
Name [2] 278543 0
Prof Michael Friedlander
Address [2] 278543 0
Department of Medical Oncology
Prince of Wales Hospital
Barker St
Randwick, NSW, 2031
Country [2] 278543 0
Australia
Other collaborator category [3] 278545 0
Individual
Name [3] 278545 0
Dr Susanna Park
Address [3] 278545 0
Brain and Mind Institute
University of Sydney
94 Mallett St
Camperdown, NSW, 2050
Country [3] 278545 0
Australia
Other collaborator category [4] 278546 0
Individual
Name [4] 278546 0
Ms Jenna Murray
Address [4] 278546 0
Institute of Neurological Sciences
Prince of Wales Hospital
High St, Level 2 Rm G.131
Randwick NSW 2031
Country [4] 278546 0
Australia
Other collaborator category [5] 278547 0
Individual
Name [5] 278547 0
A/Prof Arun Krishnan
Address [5] 278547 0
Institute of Neurological Sciences
Prince of Wales Hospital
High St, Level 2 Rm G.131
Randwick NSW 2031
Country [5] 278547 0
Australia
Other collaborator category [6] 282230 0
Individual
Name [6] 282230 0
Dr Terry Trinh
Address [6] 282230 0
Institute of Neurological Sciences Prince of Wales Hospital High St, Level 2 Rm G.131 Randwick NSW 2031
Country [6] 282230 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293231 0
South Eastern Sydney Local Health Network
Ethics committee address [1] 293231 0
Room G71, East Wing
Edmund Blackett Building
Prince of Wales Hospital
Avoca St
Randwick NSW 2031
Ethics committee country [1] 293231 0
Australia
Date submitted for ethics approval [1] 293231 0
03/06/2015
Approval date [1] 293231 0
05/06/2015
Ethics approval number [1] 293231 0
15/101

Summary
Brief summary
The major focus of the study is to assess various key aspects of Abraxane-related neurotoxicity in cancer patients, including neurophysiological assessment to ascertain the prevalence and severity of neuropathy and careful assessment of the extent of functional impairment.

Who is it for?
You can join this study if you are aged 18-75 years and are scheduled to undergo chemotherapy with either one of the following drugs; abraxane, oxaliplatin or paclitaxel for the treatment of your cancer.

Trial details
In this study, the decision to commence abraxane treatment will be made by the treating oncologist rather than by the investigators. Measures of neuropathy severity, nerve function, quality of life and physical function will be obtained in all subjects at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.

This study will provide information regarding the prevalence and functional impact of neuropathy as well as providing insights into the potential mechanisms of neurotoxicity due to Abraxane. Comparative testing in a cohort of patients treated with oxaliplatin and paclitaxel will provide information regarding the severity of neurotoxicity in abraxane-treated patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58902 0
Prof Arun Krishnan
Address 58902 0
Institute of Neurological Sciences
High St Entrance, Level 2 Rm G.131
Randwick NSW 2031
Country 58902 0
Australia
Phone 58902 0
+61293822413
Fax 58902 0
Email 58902 0
[email protected]
Contact person for public queries
Name 58903 0
Arun Krishnan
Address 58903 0
Institute of Neurological Sciences
High St Entrance, Level 2 Rm G.131
Randwick NSW 2031
Country 58903 0
Australia
Phone 58903 0
+61293822413
Fax 58903 0
Email 58903 0
[email protected]
Contact person for scientific queries
Name 58904 0
Arun Krishnan
Address 58904 0
Institute of Neurological Sciences
High St Entrance, Level 2 Rm G.131
Randwick NSW 2031
Country 58904 0
Australia
Phone 58904 0
+61293822413
Fax 58904 0
Email 58904 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.