Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000738921
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
14/07/2011
Date last updated
10/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Nerve Damage Induced by Chemotherapy
Scientific title
A randomised, double-blind, placebo-controlled, cross-over
study of the effects of calcium and magnesium (Ca Mg) infusions on the pharmacokinetics, motor nerve excitability and acute neurotoxicity symptoms of oxaliplatin, in patients having oxaliplatin chemotherapy for colorectal cancer.
Secondary ID [1] 262553 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The ChAMPION study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxaliplatin induced Neurotoxicity 268216 0
Peripheral neuropathy 268267 0
Colorectal cancer 268319 0
Condition category
Condition code
Cancer 268344 268344 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Neurological 268399 268399 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Calcium 1 gm/10 mL and magnesium 1gm/2mL administered simultaneously , or placebo of 5% Dextrose 12mL intravenous infusion, given over 20 minutes, prior to and after chemotherapy on Day1 Cycle 1 and then 21 days later on Day 1 Cycle 2
Intervention code [1] 266889 0
Prevention
Intervention code [2] 266970 0
Treatment: Other
Comparator / control treatment
Glucose 5 % intravenous solution, cross-over study
Control group
Placebo

Outcomes
Primary outcome [1] 269121 0
Intact Oxaliplatin parameters. A HPLC-tandem mass spectrometry method was developed and validated for the quantitation of intact oxaliplatin in human plasma
Timepoint [1] 269121 0
13 samples during Day 1 of each of Cycle 1 and Cycle 2 at pre treatment and 20, 40, 60, 90mins during oxaliplatin infusion, end of infusion and 5, 10, 20, 30, 60, 120, 180 minutes after the end of oxaliplatin infusion
Secondary outcome [1] 276971 0
Motor nerve excitability by electromyography
Timepoint [1] 276971 0
at Cycle 1 and at Cycle 2 Day 2 - 4
Secondary outcome [2] 276972 0
Self reported neurotoxicity symptoms and study treatment preference questionnaire
Timepoint [2] 276972 0
Self reported neurotoxicity symptoms questionnaire once on Cycle 1 and once on Cycle 2 between days 10 -20
Study treatment preference questionnaire on Cycle 2 between days 10 -20

Eligibility
Key inclusion criteria
Histologically proven colorectal cancer, eligible for standard oxaliplatin based chemotherapy, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre existing neuropathy, contra indicatins to repeated PK sampling or EMG

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised controlled trial means that allocation of subjects into different groups (i.e. intervention and control) was random or by a method based on chance by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation, stratified 2 blocks
stratification on dose, <100mg /m2 or >100mg/m2 oxaliplatin
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
20/05/2011
Date of last participant enrolment
Anticipated
Actual
5/07/2012
Date of last data collection
Anticipated
Actual
5/07/2012
Sample size
Target
12
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 3692 0
New Zealand
State/province [1] 3692 0
Auckland

Funding & Sponsors
Funding source category [1] 267364 0
Other
Name [1] 267364 0
Auckland Medical Research Foundation
Country [1] 267364 0
New Zealand
Primary sponsor type
Individual
Name
Dr Mark McKeage
Address
Associate Professor
Dept of Pharmacology and Clinical Pharmacology.
Faculty of Medical and Health Sciences
auckland University
Private bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 266432 0
None
Name [1] 266432 0
Address [1] 266432 0
Country [1] 266432 0
Other collaborator category [1] 252087 0
Hospital
Name [1] 252087 0
Auckland City Hospital
Address [1] 252087 0
85 Park Road
Grafton
Private Bag 92024
Auckland 1023
Country [1] 252087 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269346 0
Northern Y Ethics Committee
Ethics committee address [1] 269346 0
PO Box 1031
Hamilton 3204
Ethics committee country [1] 269346 0
New Zealand
Date submitted for ethics approval [1] 269346 0
08/12/2010
Approval date [1] 269346 0
12/04/2011
Ethics approval number [1] 269346 0
NTY/11/01/005

Summary
Brief summary
This clinical trial will use techniques and procedures that we have developed for measuring the plasma concentration of intact oxaliplatin and its motor nerve hyperexcitability to generate new information about the use of CaMg infusions for preventing oxaliplatin neurotoxicity. It will test the hypothesis that CaMg infusions alter the pharmacokinetics of oxaliplatin by increasing the rate of its conversion to reactive intermediates such as Pt(diaminocyclohexane)Cl2 by assessing the pharmacokinetics of intact oxaliplatin in colorectal cancer patients given the drug with and without CaMg infusions. In addition, it will test the hypothesis that CaMg infusions could prevent oxaliplatin neurotoxicity by suppressing its acute peripheral nerve hyperexcitability that will tested by needle electromyography (EMG) after oxaliplatin-based treatment given with and without CaMg infusions.

The primary objective is to evaluate the effect of administration of CaMg infusions on the plasma pharmacokinetics of intact oxaliplatin in patients with colorectal cancer. The primary endpoint is intact oxaliplatin pharmacokinetic parameters, including AUC(0-t last), AUC(0-t infinity), Cmax, t1/2, Cl, Vd and Tss. The secondary objectives are to evaluate the effects of CaMg infusions on the pharmacokinetics of total platinum, motor nerve excitability and acute neurotoxicity symptoms in patients with colorectal cancer given oxaliplatin. Secondary endpoints are total platinum pharmacokinetic parameters (AUC(0-t last), AUC(0-t infinity), Cmax, t1/2, Cl, Vd and Tss), abnormal spontaneous high-frequency motor fibre action potentials and patient-reported neurotoxicity symptoms and study treatment preference post-treatment. Exploratory objectives include determining the feasibility of investigating neurotoxicity biomarkers, and changes in plasma concentration and urinary excretion of calcium, magnesium or oxalate, in colorectal cancer patients given oxaliplatin with or without CaMg infusions.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32824 0
Dr Catherine Han
Address 32824 0
University of Auckland
85 Park Road,
Grafton, 1023
Country 32824 0
New Zealand
Phone 32824 0
+64 (0) 9 373 7599
Fax 32824 0
Email 32824 0
[email protected]
Contact person for public queries
Name 16071 0
Dr Catherine Han
Address 16071 0
University of Auckland
85 Park Road,
Grafton, 1023
Country 16071 0
New Zealand
Phone 16071 0
+64 (0) 9 373 7599
Fax 16071 0
Email 16071 0
[email protected]
Contact person for scientific queries
Name 6999 0
Catherine Han
Address 6999 0
University of Auckland
85 Park Road,
Grafton, 1023
Country 6999 0
New Zealand
Phone 6999 0
+64 (0) 9 373 7599
Fax 6999 0
+64 (0) 9 373 7927
Email 6999 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
SourceTitleYear of PublicationDOI
Dimensions AIPhase I drug-interaction study of effects of calcium and magnesium infusions on oxaliplatin pharmacokinetics and acute neurotoxicity in colorectal cancer patients2013https://doi.org/10.1186/1471-2407-13-495
N.B. These documents automatically identified may not have been verified by the study sponsor.