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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: McGill University Health Center

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: McGill University Health Center

Dates:
Date Received: February 8, 2016
Date Started: February 2016
Date Completion: December 2018
Last Updated: September 16, 2016
Last Verified: September 2016