Methadone Associated With Morphine for Cancer Pain

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03324815
• Other study ID #: 30850414.0.0000.5505
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2017
• Last updated: October 26, 2017
• Start date: March 2, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2017
• Source: Federal University of São Paulo
• Contact: Feliciano NC Duarte, MD
• Phone: 55 11 99265 7272
• Email: feliciano.contardo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Pain

Intervention

Drug:
• Morphine
Pain Treatment
• Methadone
Pain Treatment

Locations

Country	Name	City	State
Brazil	Rioko K Sakata	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Total dose of morphine used by the patient	3 months
Secondary	Pain intensity	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