Clinical trial · Interventional
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain
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
NCT02687347CI-TRIAL-00023953UDOMEunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain, Intractable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral methadone | Drug | — | UNRESOLVED |
| oral morphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- study arm
- description
- low dose methadone (1-10mg daily)
- interventionNames
- Drug: oral methadone
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- low dose morphine (1-10 mg/day)
- interventionNames
- Drug: oral morphine
Primary outcomes (2)
- measure
- pain relief
- timeFrame
- 2 months
- description
- 1\) Pain item of the Edmonton Symptom Assessment Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.