Methadone Associated With Morphine for Cancer Pain

Not Applicable

• Conditions: Cancer
• Interventions: Drug: Morphine; Drug: Methadone

• Registration Number: NCT03324815
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-03-02
• Status Verified: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30
• Primary Completion: 2018-07-30
• Study Completion: 2018-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine- Methadone	Methadone	Morphine 5mg/6h plus metadone: 2,5mg/12h
Morphine	Morphine	Morphine: 5mg/6h
Morphine- Methadone	Morphine	Morphine 5mg/6h plus metadone: 2,5mg/12h

Primary Outcome Measures

Name	Time	Method
Opioid consumption	3 months	Total dose of morphine used by the patient

Secondary Outcome Measures

Name	Time	Method
Pain intensity	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.

Trial Locations

Locations (1)

Rioko K Sakata; 🇧🇷 São Paulo, Brazil