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.

Registering a new trial?

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

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]

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

Peripheral neuropathy

Colorectal cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Neurological

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]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Glucose 5 % intravenous solution, cross-over study

Control group

Placebo

Outcomes

Primary outcome [1]

Intact Oxaliplatin parameters. A HPLC-tandem mass spectrometry method was developed and validated for the quantitation of intact oxaliplatin in human plasma

Timepoint [1]

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]

Motor nerve excitability by electromyography

Timepoint [1]

at Cycle 1 and at Cycle 2 Day 2 - 4

Secondary outcome [2]

Self reported neurotoxicity symptoms and study treatment preference questionnaire

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Auckland Medical Research Foundation

Address [1]

Auckland City Hospital
private bag 110139
Auckland1148

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Auckland City Hospital

Address [1]

85 Park Road
Grafton
Private Bag 92024
Auckland 1023

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Ethics Committee

Ethics committee address [1]

PO Box 1031 
Hamilton 3204

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/12/2010

Approval date [1]

12/04/2011

Ethics approval number [1]

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

Dr Catherine Han

Address

University of Auckland
85 Park Road,
Grafton, 1023

Country

New Zealand

Phone

+64 (0) 9 373 7599

Fax

c.han@auckland.ac.nz

Contact person for public queries

Name

Dr Catherine Han

Address

University of Auckland
85 Park Road,
Grafton, 1023

Country

New Zealand

Phone

+64 (0) 9 373 7599

Fax

c.han@auckland.ac.nz

Contact person for scientific queries

Name

Catherine Han

Address

University of Auckland
85 Park Road,
Grafton, 1023

Country

New Zealand

Phone

+64 (0) 9 373 7599

Fax

+64 (0) 9 373 7927

c.han@auckland.ac.nz

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

Source	Title	Year of Publication	DOI
Dimensions AI	Phase I drug-interaction study of effects of calcium and magnesium infusions on oxaliplatin pharmacokinetics and acute neurotoxicity in colorectal cancer patients	2013	https://doi.org/10.1186/1471-2407-13-495

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically