Methadone Associated With Morphine for Cancer Pain

October 26, 2017 updated by: Feliciano Contardo Nepomuceno Duarte, Federal University of São Paulo

Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Rioko K Sakata
        • Contact:
          • Rioko K Sakata, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Morphine- Methadone
Morphine 5mg/6h plus metadone: 2,5mg/12h
Drug: Morphine
Pain Treatment
Other Names:
  • Dimorf
Drug: Methadone
Pain Treatment
Other Names:
  • Mytedom
Active Comparator: Morphine
Morphine: 5mg/6h
Drug: Morphine
Pain Treatment
Other Names:
  • Dimorf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 3 months
Total dose of morphine used by the patient
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Rioko K Sakata, MD; PhD, Universidade Federal de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2017

Primary Completion (Anticipated)

July 30, 2018

Study Completion (Anticipated)

August 30, 2018

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30850414.0.0000.5505

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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