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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Analgesics; Methadone; Morphine

Criteria

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)