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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Intractable
• Intervention / Treatment: Drug: oral methadone; Drug: oral morphine

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • Recruiting
      • Alan Edwards Pain Management Unit. Mcgill University Health Centre
      • Contact: Jordi Perez, MD; Phone Number: 5149348222; Email: jordi.perez@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain interference	Brief Pain Inventory: Composite questions 9-A to 9-G	2 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Morphine; Methadone
• Other Study ID Numbers: 15-369 MP-CUSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic, cancer status, pain medication, symptom severity and side effects profile will be collected for each participant throughout the study; Data will be collected by clinical interview with research nurse; Data will be available to researchers immediately