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Trial registered on ANZCTR


Registration number
ACTRN12609001071213
Ethics application status
Approved
Date submitted
11/12/2009
Date registered
14/12/2009
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Case Series Investigating the efficacy of Rotation to Methadone in Palliative Patients with Cancer Related Pain
Scientific title
A Case Series Investigating change in self-rated pain following Rotation to Methadone in Palliative Patients with Cancer Related Pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesic effectiveness of rotation to methadone for palliative patients experiencing pain with both nociceptive and neuropathic qualities and that has been inadequately controlled by escalating doses of other narcotics 252294 0
Condition category
Condition code
Cancer 252474 252474 0 0
Other cancer types
Anaesthesiology 256570 256570 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 phases to this case series intervention. During Phase 1 all patients will have their baseline narcotic increased by at least 30% with actual dose being determined by the treating physician. After 3-5 days if pain levels persist above 4 on a Numeric Rating Scale (NRS) with values ranging from 0 (none) to 10 (unbearable) or the patient reports unacceptable narcotic side-effects and the patient is in agreement they will be admitted to a specialist palliative care unit (if not already an inpatient). Phase 2 involves the patient having their current narcotic ceased and an equianalgesic dose of methadone(physeptone) commenced. Patients will be ordered appropriate breakthrough medications during this time. Patients will be monitored for emergent signs of central nervous system toxicity including respiratory depression while doses of methadone are titrated until the patient is stabilized with pain scores less than 4 on the NRS. Phase 3 involves the patient being discharged home and monitored for a further 4 days. If people are improved with rotation to methadone then they can keep taking it. Throughout the study period patients will be asked to keep a daily diary. The primary outcome variable is change in rated pain from pre to post methadone rotation. The secondary outcome variables include subjective ratings of nausea and vomiting, cognitive impairment (drowsiness and unclear thinking), constipation, mood and quality of life. These changes will be assessed in the same way as subjective pain.
Duration is approximately 2 to 3 weeks
Intervention code [1] 241612 0
Treatment: Drugs
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253351 0
Mean difference in pain as rated on an 11 point NRS over the study period and global impression of pain control.
Timepoint [1] 253351 0
Participants will keep a daily diary commencing the day after the patient is consented and prior to rotation onto Physeptone until 4 days following discharge from the in-patient unit and will record all breakthrough/ rescue medications. To provide a more stable estimate of change in pain, an averaged rating over the last 3 days prior to admission will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Global impression of pain will be assessed on exit from the study
Secondary outcome [1] 262433 0
Mean difference in nausea/vomiting ratings as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [1] 262433 0
Participants will keep a daily diary for the study period. Mean nausea/vomiting ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Secondary outcome [2] 262434 0
Mean difference in drowsiness ratings as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [2] 262434 0
Participants will keep a daily diary for the study period. Mean drowsiness ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Secondary outcome [3] 262435 0
Mean difference in cognitive impairement ratings as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [3] 262435 0
Participants will keep a daily diary for the study period. Mean cognitive impairment ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Secondary outcome [4] 262436 0
Mean difference in constipation ratings as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [4] 262436 0
Participants will keep a daily diary for the study period. Mean constipation ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Secondary outcome [5] 262437 0
Mean difference in quality of life as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [5] 262437 0
Participants will keep a daily diary for the study period. Mean quality of life ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.
Secondary outcome [6] 262438 0
Mean overall mood ratings as rated on an 11 point NRS over the pre and post rotation period.
Timepoint [6] 262438 0
Participants will keep a daily diary for the study period. Mean overall mood ratings over the last 3 days prior to rotation onto Physeptone will be compared to that of the last 3 days post-discharge and subsequent exit from the study.

Eligibility
Key inclusion criteria
*Patients reporting uncontrolled pain (defined as 4 or greater on a numerical rating scale 0-10 despite the use of regular background narcotics +/- adjuvants
*A component of the patients pain must be neoropathic as assessed using a validated neuropathic pain diagnostic assessment tool, the Douleur Neuropathique en 4 (DN4)
*Able to give informed consent in English
*Willing to be admitted to an inpatient facility for rotation to methadone
*Mini mental state exam (MMSE) score = or above 25/30
*Unsuitable for, or refusing, non-pharmacological interventions e.g. nerve blocks for pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients less than 18 years of age
*Patients in whom the use of methadone is contraindicated e.g. using Monoamine oxidase inhibitors (MAOs), active alcoholism
*Patients with known risk factors for a prolonged QT interval
*Patients who have received treatments in the past 2 weeks likely to impact on pain levels e.g. chemotherapy, or who receive such therapy during the study period
*Changes in concomitant analgesic medication during the study period
*Any patient, in the opinion of the researchers, who is unable to comply with the study protocol
*Life expectancy less than 3 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2313 0
4355
Recruitment postcode(s) [2] 2314 0
4113
Recruitment postcode(s) [3] 2315 0
4350
Recruitment postcode(s) [4] 2316 0
4114
Recruitment postcode(s) [5] 2317 0
4129
Recruitment postcode(s) [6] 2318 0
4131
Recruitment postcode(s) [7] 2319 0
4178
Recruitment postcode(s) [8] 2320 0
4165
Recruitment postcode(s) [9] 2321 0
4064
Recruitment postcode(s) [10] 2322 0
4102
Recruitment postcode(s) [11] 2323 0
4179
Recruitment postcode(s) [12] 2324 0
4108
Recruitment postcode(s) [13] 2325 0
4555
Recruitment postcode(s) [14] 2326 0
4030
Recruitment postcode(s) [15] 2327 0
4169
Recruitment postcode(s) [16] 2328 0
4073
Recruitment postcode(s) [17] 2329 0
4567
Recruitment postcode(s) [18] 2330 0
4551
Recruitment postcode(s) [19] 2331 0
4558
Recruitment postcode(s) [20] 2332 0
4573
Recruitment postcode(s) [21] 2333 0
4110
Recruitment postcode(s) [22] 2334 0
4103
Recruitment postcode(s) [23] 2335 0
4170
Recruitment postcode(s) [24] 2336 0
4171
Recruitment postcode(s) [25] 2337 0
4077
Recruitment postcode(s) [26] 2338 0
4163
Recruitment postcode(s) [27] 2339 0
4121
Recruitment postcode(s) [28] 2340 0
4073
Recruitment postcode(s) [29] 2341 0
4109
Recruitment postcode(s) [30] 2342 0
4119
Recruitment postcode(s) [31] 2343 0
4104
Recruitment postcode(s) [32] 2344 0
4115

Funding & Sponsors
Funding source category [1] 256093 0
Other Collaborative groups
Name [1] 256093 0
Brisbane South Palliative Care Collaborative
Country [1] 256093 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brisbane South Palliative Care Collaborative
Address
PO Box 4069 Eight Mile Plains Brisbane QLD 4113
Country
Australia
Secondary sponsor category [1] 251435 0
None
Name [1] 251435 0
Address [1] 251435 0
Country [1] 251435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258182 0
Princess Alexandra Hospital
Ethics committee address [1] 258182 0
Office of the Human Research Ethics Committee ipswich Road Wooloongabba QLD 4102
Ethics committee country [1] 258182 0
Australia
Date submitted for ethics approval [1] 258182 0
01/09/2009
Approval date [1] 258182 0
18/11/2009
Ethics approval number [1] 258182 0
HREC/09/QPAH/227

Summary
Brief summary
This project has been designed to investigate the efficacy of rotation to methadone for pain control in people with cancer whose pain is uncontrolled despite substantial increases in the dose of their prescribed narcotic. By uncontrolled we mean that the person has rated their pain as being equal to or above 4 on an 11 point pain rating scale that ranges from 0 (equivalent to no pain at all), to 10 (equivalent to unbearable pain). To be eligible for this study, a person’s pain must have been clinically assessed to have two different components. One component relates to the type of pain that results when injured body tissues cause pain receptors to fire (known as nociceptive pain) and the other component relates to the type of pain that results when nervous tissues is damaged (known as neuropathic pain). People who meet these conditions will be rotated to a dose of methadone that is equivalent to their previous narcotic does in terms of analgesic potential. They will be required to maintain a daily diary about their pain levels, possible narcotic side effects (such as constipation), quality of life and mood. Diary entries before rotation to methadone will be compared statistically to diary entries after rotation to methadone. If people are improved with rotation to methadone then they can keep taking it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30554 0
Address 30554 0
Country 30554 0
Phone 30554 0
Fax 30554 0
Email 30554 0
Contact person for public queries
Name 13801 0
Fiona Israel
Address 13801 0
PO Box 4069
Eight Mile Plains QLD 4113
Country 13801 0
Australia
Phone 13801 0
+61 7 3169 9875
Fax 13801 0
+61 7 3169 9885
Email 13801 0
[email protected]
Contact person for scientific queries
Name 4729 0
A/Prof Liz Reymond
Address 4729 0
PO Box 4069
Eight Mile Plains QLD 4113
Country 4729 0
Australia
Phone 4729 0
+61 7 3169 9867
Fax 4729 0
+61 7 3169 9885
Email 4729 0
[email protected]

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Results publications and other study-related documents

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