Pain, Intractable
Conditions
Brief summary
The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.
Interventions
DRUGoral methadone
Oral methadone is the study drug
DRUGoral morphine
Oral morphine is the active comparator. It is not a placebo intervention
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed of cancer-related pain of more than 3 months duration * Pain relief during the last week rated unsatisfactory by the patient * Pain severity during the last week rated moderate (between 4 and 7/10) * Analgesic therapy must have been stable for 7 days * Able to understand English or French * Willing and able to give written informed consent
Exclusion criteria
* Patients who are currently receiving or have received methadone as analgesic in the last 6 months * Contraindication to receive methadone (allergy, QTc segment on the ECG\>450msec, concurrent treatment with medication that could increase methadone's effects) * Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy) * Patients whose life expectancy is shorter than 2 months * Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires * Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain relief | 2 months | 1\) Pain item of the Edmonton Symptom Assessment Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 2 months | prevalence and severity of opioid induced side effects |
Other
| Measure | Time frame | Description |
|---|---|---|
| pain interference | 2 months | Brief Pain Inventory: Composite questions 9-A to 9-G |
Countries
Canada
Outcome results
None listed