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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2018

Interventions

  • Drug: oral methadone
    • Oral methadone is the study drug
  • Drug: oral morphine
    • Oral morphine is the active comparator. It is not a placebo intervention

Arms, Groups and Cohorts

  • Experimental: study arm
    • low dose methadone (1-10mg daily)
  • Active Comparator: control arm
    • low dose morphine (1-10 mg/day)

Clinical Trial Outcome Measures

Primary Measures

  • pain relief
    • Time Frame: 2 months
    • 1) Pain item of the Edmonton Symptom Assessment Scale
  • pain relief
    • Time Frame: 2 months
    • Questions 3 to 6 of the Brief Pain Inventory

Secondary Measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0″.
    • Time Frame: 2 months
    • prevalence and severity of opioid induced side effects

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jordi Perez, Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada – McGill University Health Centre/Research Institute of the McGill University Health Centre

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