Sublingual methadone for the management of cancer-related procedural pain in inpatients

ISRCTN	ISRCTN72738824
DOI	https://doi.org/10.1186/ISRCTN72738824
ClinicalTrials.gov (NCT)	NCT00351637
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: 26/04/2006
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

Phone	+1 403 521 3446
Email	neilha@cancerboard.ab.ca

Study information

Primary study design	Interventional
Study design	Open label multicentre prospective trial
Secondary study design	Cohort study
Scientific title	Sublingual methadone for the management of cancer-related procedural pain in inpatients: a phase II multicentre, open label, feasibility study
Study acronym	SLM INPT
Study objectives	The overall goal of this research is to evaluate the effectiveness of sublingual methadone for cancer-related breakthrough pain (onset to time of meaningful relief and the duration of the relief of breakthrough pain). The overall hypothesis is that sublingual methadone, once optimal dose has been reached, will pre-empt or relieve moderate to severe treatment-related, incident pain within five minutes in at least half of episodes evaluated. The purpose of this phase II study is to determine the feasibility of the dose titration and assessment protocol in the inpatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.
Ethics approval(s)	Conjoint Health Research Ethics Board, original approval dated 18th May 2006; amendment approval granted 24th August 2006
Health condition(s) or problem(s) studied	Cancer-related breakthrough pain
Intervention	Sublingual methadone
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Methadone
Primary outcome measure(s)	The primary objective of this current phase II study is to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic, treatment-related incident breakthrough pain. Specific aspects of feasibility are: 1. To demonstrate the feasibility of recruitment to a study for incident pain in the inpatient setting 2. Feasibility of dose titration in the inpatient setting 3. Feasibility of filling out the pain assessments 4. Provide preliminary evidence of efficacy 5. To provide further information to document safety of the model
Key secondary outcome measure(s)	1. To develop a model of pharmacokinetic (PK) or 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
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Pain due to cancer or its treatment 2. Controlled baseline pain 3. Episodes of predictable, treatment-related pain every day that are 4/10 in severity or greater, last ten minutes or longer, or episodes of breakthrough pain not related to cancer treatment, 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 two-minute period 5. Able to provide written, informed consent 6. Able to fill out the study forms, and must be an inpatient
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. Clinically unstable or a life expectancy of less than one month making completion of the trial unlikely 5. Patients who do not have an understanding of English enough to provide written, informed consent
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 2012 due to low accrual