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Methadone Associated With Morphine for Cancer Pain

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: NCT03324815
Recruitment Status : Unknown
Verified October 2017 by Feliciano Contardo Nepomuceno Duarte, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Feliciano Contardo Nepomuceno Duarte, Federal University of São Paulo

Brief Summary:
The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Condition or disease Intervention/treatment Phase
Cancer Drug: Morphine Drug: Methadone Not Applicable

Detailed Description:
Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Morphine- Methadone
Morphine 5mg/6h plus metadone: 2,5mg/12h
Drug: Morphine
Pain Treatment
Other Name: Dimorf

Drug: Methadone
Pain Treatment
Other Name: Mytedom

Active Comparator: Morphine
Morphine: 5mg/6h
Drug: Morphine
Pain Treatment
Other Name: Dimorf

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 3 months ]
    Total dose of morphine used by the patient

Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 3 months ]
    Measure of pain intensity by verbal numerical rating score (VNRS - zero to 10) where 0 is no pain and 10 is the worst pain imaginable. Values between 0 and 3 mean a good result, between 4 and 6 a poor result and between 7 and 10 a very poor result.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Approved by the Ethics Committee
  • signed the informed consent
  • cancer pain
  • starting the WHO thirth analgesic ladder,

Exclusion Criteria:

  • cognitive impairment
  • psychiatric disease
  • illicit drug user
  • hypersensitivity to the study drugs
  • pregnant

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): NCT03324815

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Contact: Feliciano NC Duarte, MD 55 11 99265 7272

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Rioko K Sakata Recruiting
São Paulo, Brazil
Contact: Rioko K Sakata, PhD         
Sponsors and Collaborators
Federal University of São Paulo
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Principal Investigator: Rioko K Sakata, MD; PhD Universidade Federal de São Paulo

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Responsible Party: Feliciano Contardo Nepomuceno Duarte, Principal Investigator, Federal University of São Paulo Identifier: NCT03324815     History of Changes
Other Study ID Numbers: 30850414.0.0000.5505
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Feliciano Contardo Nepomuceno Duarte, Federal University of São Paulo:
Additional relevant MeSH terms:
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Cancer Pain
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