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Trial record 50 of 1127 for:    Oral Cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02687347
Recruitment Status : Unknown
Verified September 2016 by Jordi Perez, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
Jordi Perez, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Pain, Intractable Drug: oral methadone Drug: oral morphine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. pain relief [ Time Frame: 2 months ]
    1) Pain item of the Edmonton Symptom Assessment Scale

  2. pain relief [ Time Frame: 2 months ]
    Questions 3 to 6 of the Brief Pain Inventory

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. pain interference [ Time Frame: 2 months ]
    Brief Pain Inventory: Composite questions 9-A to 9-G

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02687347

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Canada, Quebec
Alan Edwards Pain Management Unit. Mcgill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Jordi Perez, MD    5149348222   
Sponsors and Collaborators
McGill University Health Center

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Responsible Party: Jordi Perez, Codirector Cancer Pain Program. McGill University Health Centre. Montreal, Canada, McGill University Health Center Identifier: NCT02687347     History of Changes
Other Study ID Numbers: 15-369 MP-CUSM
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. Demographic, cancer status, pain medication, symptom severity and side effects profile will be collected for each participant throughout the study
  2. Data will be collected by clinical interview with research nurse
  3. Data will be available to researchers immediately

Additional relevant MeSH terms:
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Pain, Intractable
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents