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

Primary Purpose

Pain, Intractable

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
oral methadone
oral morphine
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Intractable

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Alan Edwards Pain Management Unit. Mcgill University Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study arm

control arm

Arm Description

low dose methadone (1-10mg daily)

low dose morphine (1-10 mg/day)

Outcomes

Primary Outcome Measures

pain relief
1) Pain item of the Edmonton Symptom Assessment Scale
pain relief
Questions 3 to 6 of the Brief Pain Inventory

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
prevalence and severity of opioid induced side effects

Full Information

First Posted
February 8, 2016
Last Updated
September 16, 2016
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02687347
Brief Title
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain
Acronym
UDOME
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
low dose methadone (1-10mg daily)
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
low dose morphine (1-10 mg/day)
Intervention Type
Drug
Intervention Name(s)
oral methadone
Intervention Description
Oral methadone is the study drug
Intervention Type
Drug
Intervention Name(s)
oral morphine
Intervention Description
Oral morphine is the active comparator. It is not a placebo intervention
Primary Outcome Measure Information:
Title
pain relief
Description
1) Pain item of the Edmonton Symptom Assessment Scale
Time Frame
2 months
Title
pain relief
Description
Questions 3 to 6 of the Brief Pain Inventory
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Description
prevalence and severity of opioid induced side effects
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
pain interference
Description
Brief Pain Inventory: Composite questions 9-A to 9-G
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Alan Edwards Pain Management Unit. Mcgill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Perez, MD
Phone
5149348222
Email
jordi.perez@muhc.mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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