CClinicalTrials.gg
Status unknownNCT03324815Updated Oct 30, 2017

Methadone Associated With Morphine for Cancer Pain

An interventional study of Morphine and Methadone in Cancer, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-30.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer

Browse trials for

Keywords

  • Morphine
  • Methadone
  • Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • cognitive impairment
  • psychiatric disease
  • illicit drug user
  • hypersensitivity to the study drugs
  • pregnant
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Morphine- Methadone

    Morphine 5mg/6h plus metadone: 2,5mg/12h

    Drug: Morphine · Drug: Methadone

  • Active comparator
    Morphine

    Morphine: 5mg/6h

    Drug: Morphine

Interventions

  • DrugMorphine

    Pain Treatment

    Also known as: Dimorf

  • DrugMethadone

    Pain Treatment

    Also known as: Mytedom

05

What researchers measure

Primary outcomes

  1. Opioid consumption

    Total dose of morphine used by the patient

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • Rioko K Sakata
    São Paulo, Brazil
    • Rioko K Sakata, PhD · Contact
    Recruiting
07

References and documents

Publications

  • Duarte FCN, Ferraro LHDC, Ferreira A, Sakata RK. A Randomized Controlled Trial Evaluating the Analgesic Effect of the Combination of Methadone With Morphine for Cancer Related Pain. Clin J Pain. 2021 Sep 1;37(9):664-668. doi: 10.1097/AJP.0000000000000959. PubMed 34265791 ↗
08

Registry details

Key details

Study ID
NCT03324815
Lead sponsor
Federal University of São Paulo
Responsible party
Feliciano Contardo Nepomuceno Duarte (Principal Investigator, Federal University of São Paulo) — Principal investigator
First posted
Oct 30, 2017
Start date
Mar 2, 2017
Primary completion
Jul 30, 2018 (estimated)
Completion
Aug 30, 2018 (estimated)
Last update
Oct 30, 2017

Study contacts

Feliciano NC Duarte, MD
Contact
feliciano.contardo@gmail.com
55 11 99265 7272
Rioko K Sakata, MD; PhD
principal investigator · Universidade Federal de São Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion