Cancer, Pain
Conditions
Keywords
Sublingual Methadone, Cancer related breakthrough pain, feasibility study, Phase II/open label, Outpatients, Safety/ efficacy, previously receiving opioids, speak English
Brief summary
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population 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 optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.
Interventions
Sponsors
University of Calgary
AHS Cancer Control Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pain due to cancer or its treatment; controlled baseline pain; * episodes of breakthrough pain every day that are 4/10 in severity or greater, ; * ast 10 minutes or longer, and * are responsive to short acting oral opioids such as morphine or hydromorphone; * are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent; * are able to fill out the study forms
Exclusion criteria
* Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid; * prior sensitivity to methadone; * currently are being administered methadone; * have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain, * new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain); * are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| to develop a model of PK/PD study of breakthrough pain | Baseline to 5 years |
| to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT) | Baseline to 5 years |
| to demonstrate proof of concept | Baseline to 5 years |
Countries
Canada
Outcome results
None listed