Sublingual methadone for the management of cancer-related breakthrough pain in outpatients

ISRCTN	ISRCTN61713542
DOI	https://doi.org/10.1186/ISRCTN61713542
ClinicalTrials.gov (NCT)	NCT00351715
Protocol serial number	N/A
Sponsor	Alberta Cancer Board (Canada)
Funders	Alberta Cancer Board (Canada) - Competition (ref: 4640), Infrastructural support by Canadian Institutes of Health Research (CIHR) grant number: PET 69772 - we received funding for Difficult Pain Problems NET Grant. The monies received were to provide infrastructural support for research or network activities across Canada.

Submission date: 01/05/2006
Registration date: 06/07/2006
Last edited: 31/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Hagen
Scientific

Room 374
Heritage Medical Research Building
3330 Hospital Dr. N.W.
Calgary
T2N 4N1
Canada

Email	neilha@cancerboard.ab.ca

Study information

Primary study design	Interventional
Study design	Open label feasibility study
Secondary study design	Cohort study
Scientific title	Sublingual methadone for the management of cancer-related breakthrough pain in outpatients: a phase II multicentre, open label, feasibility study
Study acronym	SLM OUTPT
Study objectives	The overall hypothesis is that sublingual methadone, once optimal dose has been reached, will relieve moderate to severe breakthrough pain within five minutes in at least half of episodes evaluated.
Ethics approval(s)	Conjoint Health Research Ethics Board, original approval 18th May 2006; amendment approval 5th October 2006.
Health condition(s) or problem(s) studied	Cancer-related breakthrough pain
Intervention	Sublingual methadone
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Methadone
Primary outcome measure(s)	To demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting. Specific aspects of feasibility are: 1. To demonstrate the feasibility of recruitment to a study for incident pain in the outpatient setting 2. Feasibility of dose titration in the outpatient setting 3. Feasibility of filling out the pain assessments 4. Provide preliminary evidence of efficacy 5. Provide further information to document safety of the model
Key secondary outcome measure(s)	1. To develop a model of pharmacokinetic (PK) and pharmacodynamic (PD) study of breakthrough pain 2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT) 3. To demonstrate proof of concept, with half of patients obtaining meaningful pain reduction within five minutes of administration, when given the identified optimal dose
Completion date	31/12/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	42
Key inclusion criteria	Patients aged 18 years and older are eligible if they have: 1. Pain due to cancer or its treatment 2. Controlled baseline pain 3. Episodes of breakthrough pain every day that are 4/10 in severity or greater, last ten minutes or longer, and are responsive to short acting oral opioids such as morphine or hydromorphone 4. Able to hold a volume of 1.0 cc of water under the tongue for a five minute period 5. Able to provide written, informed consent 6. Able to fill out the study forms
Key exclusion criteria	1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid 2. Prior sensitivity to methadone 3. Currently taking methadone 4. Breakthrough pain that in the opinion of the investigator is likely to change within the next seven days as a result of any of the following: 4.1. Recent or imminent radiation therapy to the main site of pain 4.2. New use of chemotherapy 4.3. Use of an injectable bisphosphonate likely to alter the pain 4.4. New use of corticosteroids within the past week with a corresponding change in pain 4.5. Other interventions judged likely to alter the pain 5. Are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Date of first enrolment	01/06/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Canada

Study participating centre

Room 374

Calgary
T2N 4N1
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/01/2019: Clinicaltrials.gov states that this trial was terminated by January 2013 due to low accrual