Sublingual methadone for the management of cancer-related breakthrough pain in outpatients
| ISRCTN | ISRCTN61713542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61713542 |
| ClinicalTrials.gov number | NCT00351715 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Room 374
Heritage Medical Research Building
3330 Hospital Dr. N.W.
Calgary
T2N 4N1
Canada
| neilha@cancerboard.ab.ca |
Study information
| Study design | Open label feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methadone |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2006 |
| 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 | Both |
| Target number of participants | 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
T2N 4N1
Canada
Sponsor information
Alberta Cancer Board (Canada)
Charity
Charity
1220 Standard Life Building
10405 Jasper Avenue
Edmonton
T5J 3N4
Canada
| barbhisc@cancerboard.ab.ca | |
| Website | http://www.cancerboard.ab.ca/ |
"ROR" |
https://ror.org/01k1b2g25 |
Funders
Funder type
Charity
Alberta Cancer Board (Canada) - Competition (ref: 4640)
No information available
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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
