Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000501448
Ethics application status
Approved
Date submitted
20/09/2007
Date registered
28/09/2007
Date last updated
27/03/2023
Date data sharing statement initially provided
27/03/2023
Date results information initially provided
27/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, double-blind placebo controlled study of subcutaneous ketamine in the management of cancer pain
Scientific title
A Randomised, double-blind placebo controlled study of subcutaneous ketamine in the management of cancer pain
Secondary ID [1] 251757 0
001/07
Universal Trial Number (UTN)
Trial acronym
Ketamine for cancer pain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain from cancer or cancer treatment 2386 0
Condition category
Condition code
Cancer 2490 2490 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
phase III randomised, double blind, placebo controlled trial of ketamine 100mg to 300 mg then 500mg (if not responding) delivered by subcutaneous infusion over 24 hours for 5 days.
Intervention code [1] 2110 0
Treatment: Drugs
Comparator / control treatment
Normal Saline 15 mls, over subcutaneous infusion over 24 hours for 5 days.
Control group
Placebo

Outcomes
Primary outcome [1] 3386 0
The primary outcome is the pain score on day 6.
Timepoint [1] 3386 0
Day 6
Secondary outcome [1] 5619 0
Brief Pain Inventory average pain score at start days 1-6
Timepoint [1] 5619 0
Day 6
Secondary outcome [2] 5659 0
Performance Status at baseline and end of treatment
Timepoint [2] 5659 0
Day 6
Secondary outcome [3] 5660 0
Opioid use, including number of breakthrough doses
Timepoint [3] 5660 0
Day 6
Secondary outcome [4] 5661 0
Pain relief and quality of life
Timepoint [4] 5661 0
Day 2

Eligibility
Key inclusion criteria
•age >18 years
•pain related to cancer or its treatment
•moderate to severe pain
•patients with primarily nociceptive pain (Leeds Assessment of Neuropathic Symptoms and Signs score <12), or patients with predominantly neuropathic pain (Leeds Assessment of Neuropathic Symptoms and Signs score >12) treated appropriately
•stable backgound opioid dose
•stable co-analgesics during the study period
•patient is able to give fully informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous ketamine use Unstable pain, or undergoing active treatment to reduce pain (surgery, chemotherapy, radiotherapy) Medical history places patient at risk of known adverse reactions Pregnacny/ lactation Previous recreaional drug history Recent Monoamine oxidase inhibitors (non-reversible monoamine oxidase inhibitors are excluded for 4 weeks, reversible monoamine oxidase inhibitors are excluded for 2 days).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At each centre, patients will be sequentially allocated a patient number.
All syringes will be prepared by the site clinical trial pharmacist according to the randomisation schedule, each syringe will be numbered according to the pre-determined randomisation code and labeled as ketamine/placebo 100, 300 or 500mg. All syringes will look identical in volume and colour to protect the blinding irrespective of the contents.
All new in-patients under the care or shared care of the palliative care team will be screened by the study nurse for their suitability to enter the study. The study nurse will ask the consultant in charge for permission to approach potentially eligible patients. This referral will be recorded within both the CRF and the patient clinical file.
Screening
If patients are suitable for entry and prepared to consent to the study, they will undergo baseline assessments and assessment of eligibility criteria and commence study the following morning. A screening log will be kept of all potentially eligible patients including the reasons for non entry.
At all times, from eligibility screening to completion of the study, all study staff are unaware of the treatment allocation. Allocation is concealed from the investigator at the time of the participant inclusion in the trial, the allocation is determined by contacting the site pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment for each patient will be allocated according to a block randomisation schedule held by the central registry in a 1:1 ratio. Block randomisation will ensure even allocation to each code. The central registry will supply strata tables to each site pharmacy.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There is a dose modification schedule, and a resuce medication protocol for ketamine toxicity, opioid toxicity, and Psychomimetic toxicity.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
28/03/2008
Date of last participant enrolment
Anticipated
Actual
2/02/2011
Date of last data collection
Anticipated
Actual
7/02/2011
Sample size
Target
150
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 2635 0
Government body
Name [1] 2635 0
Commonwealth Department of Health and Ageing
Country [1] 2635 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive
Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 2382 0
Government body
Name [1] 2382 0
Department of Health and Ageing
Address [1] 2382 0
Canberra
Country [1] 2382 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4556 0
Repatriation General Hospital
Ethics committee address [1] 4556 0
Daws Road
Daw Park SA 5041
Ethics committee country [1] 4556 0
Australia
Date submitted for ethics approval [1] 4556 0
27/09/2007
Approval date [1] 4556 0
30/01/2008
Ethics approval number [1] 4556 0
EC00191
Ethics committee name [2] 4573 0
Hope Healthcare
Ethics committee address [2] 4573 0
Braeside Hospital
Locked Bag 82
Wetherill Park, NSW 2164
Ethics committee country [2] 4573 0
Australia
Date submitted for ethics approval [2] 4573 0
27/09/2007
Approval date [2] 4573 0
07/12/2007
Ethics approval number [2] 4573 0
EC00425
Ethics committee name [3] 5259 0
Flinders Clinical Research Ethics Committee
Ethics committee address [3] 5259 0
Flinders Medical Centre
Bedford Park, SA 5042
Ethics committee country [3] 5259 0
Australia
Date submitted for ethics approval [3] 5259 0
23/10/2007
Approval date [3] 5259 0
27/03/2008
Ethics approval number [3] 5259 0
EC00188
Ethics committee name [4] 5260 0
South Western Sydney Area Health Service Human Research Ethics Committee
Ethics committee address [4] 5260 0
Research Development Office
Level 8, Building 14
Royal Prince Alfred Hospital
Missendon Road
Camberdown, NSW, 2050
Ethics committee country [4] 5260 0
Australia
Date submitted for ethics approval [4] 5260 0
12/11/2007
Approval date [4] 5260 0
25/03/2008
Ethics approval number [4] 5260 0
EC00136
Ethics committee name [5] 5261 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [5] 5261 0
Raymond Tce South Brisbane, QLD, 4101
Ethics committee country [5] 5261 0
Australia
Date submitted for ethics approval [5] 5261 0
15/11/2007
Approval date [5] 5261 0
26/02/2008
Ethics approval number [5] 5261 0
EC00332
Ethics committee name [6] 5262 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [6] 5262 0
Peter MacCallum Cancer Centre St Marys Place East Melbourne Vic 3002
Ethics committee country [6] 5262 0
Australia
Date submitted for ethics approval [6] 5262 0
19/11/2007
Approval date [6] 5262 0
01/04/2008
Ethics approval number [6] 5262 0
EC00235
Ethics committee name [7] 258958 0
Alfred Hospital Ethics Committee
Ethics committee address [7] 258958 0
Alfred Hospital, Commercial Road, Melbourne Victoria, 3004
Ethics committee country [7] 258958 0
Australia
Date submitted for ethics approval [7] 258958 0
16/11/2009
Approval date [7] 258958 0
01/02/2010
Ethics approval number [7] 258958 0
EC00315
Ethics committee name [8] 258959 0
St John of God Health Care Ethics Committee
Ethics committee address [8] 258959 0
Level 3
St John of God House, 177-179 Cambridge Street, WEMBLEY WA 6014
Ethics committee country [8] 258959 0
Australia
Date submitted for ethics approval [8] 258959 0
06/08/2009
Approval date [8] 258959 0
19/03/2010
Ethics approval number [8] 258959 0
EC00286
Ethics committee name [9] 258960 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [9] 258960 0
Hollywood Private Hospital Ethics Committee
Locked Bag 2002
NEDLANDS WA 6009
Ethics committee country [9] 258960 0
Australia
Date submitted for ethics approval [9] 258960 0
12/11/2007
Approval date [9] 258960 0
07/11/2008
Ethics approval number [9] 258960 0
EC00266
Ethics committee name [10] 258961 0
St Vincent's Hospital (Melbourne) HREC D
Ethics committee address [10] 258961 0
Research Governance Unit
PO Box 2900
FITZROY VIC 3065
Ethics committee country [10] 258961 0
Australia
Date submitted for ethics approval [10] 258961 0
30/04/2009
Approval date [10] 258961 0
22/09/2009
Ethics approval number [10] 258961 0
EC00344

Summary
Brief summary
This study looks at the effectiveness of the pain-killing drug ketamine in people with widespread cancer who are receiving palliative care and have difficult cancer pain that does not respond well to opioid drugs.

Who is it for?
You can join this study if you have widespread cancer and are receiving palliative care, and have difficult cancer pain that does not respond well to opioid (morphine-like) drugs.

Trial details
Participants will be divided into two groups. One group will receive five days of treatment with increasing doses of ketamine given under the skin (sub-cutaneously), and the other will receive a non-active compound (placebo) also given under the skin. Blood samples will be collected. The study will assess pain control, quality of life, side effects from ketamine, and reduction in the need for usual pain medicines. The study nurses and the doctors and nurses in the ward will monitor all participants closely for any unexpected problems and to ensure that pain is managed appropriately. Ketamine may be helpful for pain related to cancer, especially pain resulting from nerve damage. However studies to date are incomplete and evidence is needed to support continued clinical use. It is hoped that after this study, if ketamine is proven safe and effective in difficult cancer pain, it will become more easily available for Australian cancer patients.
Trial website
Trial related presentations / publications
Janet Hardy , Stephen Quinn, Belinda Fazekas, John Plummer, Simon Eckermann, Meera Agar, Odette Spruyt, Debra Rowett and David C. Currow. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Toxicity of Subcutaneous Ketamine in the Management of Cancer Pain. J Clin Oncol. 2012 Oct 10;30(29):3611-7.
Public notes

Contacts
Principal investigator
Name 28062 0
Prof Janet Hardy
Address 28062 0
Mater Health Services
Raymond Terrace
South Brisbane
QLD, 4101
Country 28062 0
Australia
Phone 28062 0
+61 7 31632775
Fax 28062 0
Email 28062 0
Janet.Hardy@mater.org.au
Contact person for public queries
Name 11219 0
Prof Prof Janet Hardy
Address 11219 0
Director Of Palliative Care
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101
Country 11219 0
Australia
Phone 11219 0
07 3163 2775/8074/8545
Fax 11219 0
07 3163 8856
Email 11219 0
janet.hardy@mater.org.au
Contact person for scientific queries
Name 2147 0
Prof Prof Janet Hardy
Address 2147 0
Director Of Palliative Care
Mater Health Services
Raymond Terrace
South Brisbane
QLD 4101
Country 2147 0
Australia
Phone 2147 0
07 3840 2775/8074/8545
Fax 2147 0
07 3840 8856
Email 2147 0
janet.hardy@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and secondary outcome IPD
Data Dictionary
Protocol
When will data be available (start and end dates)?
01/06/2023 to 01/06/2027
Available to whom?
Researchers undertaking secondary research
Available for what types of analyses?
Those analyses described in approved proposals only
How or where can data be obtained?
Anyone who wishes to access the data should submit a proposal to itcc@uts.edu.au. If approved, data requestors will need to sign a data access agreement. After that,the ITCC Data Center will transfer the requested data and other documents to data requestors.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18706Study protocol  itcc@uts.edu.au
18707Clinical study report  itcc@uts.edu.au
18708Ethical approval  itcc@uts.edu.au
18709Informed consent form  itcc@uts.edu.au


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCYP2B6*6 allele and age substantially reduce steady-state ketamine clearance in chronic pain patients: Impact on adverse effects.2015https://dx.doi.org/10.1111/bcp.12614
N.B. These documents automatically identified may not have been verified by the study sponsor.