Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain

Conditions
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Pain, Intractable

Intervention / Treatment
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* Drug: oral methadone
* Drug: oral morphine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study arm<br>low dose methadone (1-10mg daily) | Drug: oral methadone<br>* Oral methadone is the study drug<br>|
| Active Comparator: control arm<br>low dose morphine (1-10 mg/day) | Drug: oral morphine<br>* Oral morphine is the active comparator. It is not a placebo intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | 1) Pain item of the Edmonton Symptom Assessment Scale | 2 months | 
| pain relief | Questions 3 to 6 of the Brief Pain Inventory | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | prevalence and severity of opioid induced side effects | 2 months |