Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000029897
Ethics application status
Approved
Date submitted
22/11/2011
Date registered
9/01/2012
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting Nerve Damage Induced by Chemotherapy
Scientific title
Biological correlates of chemotherapy-induced neurotoxicity: a prospective cohort study of cancer patients undergoing treatment with cisplatin, oxaliplatin or paclitaxel. Prospectively Investigating Chemotherapy Neurotoxicty
Secondary ID [1] 273589 0
Northern X Regional Ethics Committee NTX /11/06/051
Universal Trial Number (UTN)
Nil
Trial acronym
PICNic
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy-induced neurotoxicity in cancer patients 270404 0
Condition category
Condition code
Cancer 285566 285566 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is observing the effect of standard chemotherapies Oxaliplatin , cisplatin and paclitaxel on neurotoxicity. These chemotherapy treatments are given intravenously through a wide range of doses, patients may have 3 or 4 weekly cycles that may continue for between 4 and 10 cycles. This observational study will last approximately 6 months.
Intervention code [1] 283759 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285990 0
patient neurotoxicity outcomes after treatment with cisplatin, oxaliplatin and paclitaxel chemotherapy, for correlation with biological variables measured in blood samples
Timepoint [1] 285990 0
Blood specimens will be collected prior to treatment, prior to cycle 2, at end of treatment and 3 months after treatment.
Primary outcome [2] 285991 0
Change in Total Neuropathy Score (Clinical)
Timepoint [2] 285991 0
from baseline to 3 months after treatment
Secondary outcome [1] 294909 0
Change on audiogram parameters measured by the severity grade for hearing toxicity
Timepoint [1] 294909 0
from baseline to 3 months after cisplatin treatment
Secondary outcome [2] 294910 0
occurrence of treatment-limiting neurotoxicity measured by changes in the neurotoxicity quality of life score questionnaire
Timepoint [2] 294910 0
from baseline to 3 months after treatment

Eligibility
Key inclusion criteria
Written informed consent Inclusion criteria
All adult male or female patients with cancer of any type presenting for standard chemotherapy that includes cisplatin, oxaliplatin or paclitaxel are candidates for study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Unable for give informed consent
Expected survival less than 6 months
Age less than 18 years

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2011
Actual
30/08/2011
Date of last participant enrolment
Anticipated
Actual
28/09/2016
Date of last data collection
Anticipated
Actual
28/12/2016
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 3748 0
New Zealand
State/province [1] 3748 0
Auckland

Funding & Sponsors
Funding source category [1] 284238 0
University
Name [1] 284238 0
University of Auckland
Country [1] 284238 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Dept of Pharmacology and Clinical Pharmacology,
The University of Auckland
85 Park Road, Grafton
Private Bag 92019
AUCKLAND
Country
New Zealand
Secondary sponsor category [1] 269194 0
None
Name [1] 269194 0
Address [1] 269194 0
Country [1] 269194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286203 0
Northern Y Ethics Committee
Ethics committee address [1] 286203 0
Ethics committee country [1] 286203 0
New Zealand
Date submitted for ethics approval [1] 286203 0
19/05/2011
Approval date [1] 286203 0
07/07/2011
Ethics approval number [1] 286203 0
NTX/11/06/051

Summary
Brief summary
This is a study that will collect information about patient neurotoxicity outcomes after treatment with cisplatin, oxaliplatin and paclitaxel chemotherapy, for correlation with biological variables measured in blood samples collected at baseline or during the initial course of treatment.
The study population will include adult patients with any cancer type, who will have standard chemotherapy with cisplatin, oxaliplatin or paclitaxel, who are able to give informed consent, who are over 18 years old and who are expected to survive for more than six months. The patient neurotoxicity outcomes to be measured in this study include the change between baseline and three months after treatment in the Total Neuropathy Score Clinical, which is a clinical test, the neurotoxicity quality of life score, which is a questionnaire, the severity grade for hearing toxicity, measured by an audiogram and the occurrence of treatment-limiting neurotoxicity. Samples of blood will be collected at baseline, on cycle 1 day 1 and at the end of cycle 1 for preparation of plasma RNA and DNA biomarker samples. There will be 300 patients in total and in each group at least 100 patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32924 0
Prof Mark McKeage
Address 32924 0
FMHS, University of Auckland
85 Park Road, Grafton, Auckland, 1023
Department of Pharmacology & clinical pharmacology
Country 32924 0
New Zealand
Phone 32924 0
+64 9 9237322
Fax 32924 0
Email 32924 0
[email protected]
Contact person for public queries
Name 16171 0
Miss Prashannata Khwaounjoo
Address 16171 0
FMHS, University of Auckland
85 Park Road, Grafton, Auckland, 1023
Department of Pharmacology & clinical pharmacology
Country 16171 0
New Zealand
Phone 16171 0
+64 9 9231594
Fax 16171 0
+64 9 9237584
Email 16171 0
[email protected]
Contact person for scientific queries
Name 7099 0
Prof Associate Professor Mark McKeage
Address 7099 0
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1023
New Zealand

+64 21 859 588
Country 7099 0
New Zealand
Phone 7099 0
+64 9 923 7322
Fax 7099 0
+64 9 3737927
Email 7099 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
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