CancerNCT03324815
Methadone Associated With Morphine for Cancer Pain
A study testing Morphine and Methadone in people with Cancer, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Morphine and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approved by the Ethics Committee
- signed the informed consent
- cancer pain
- starting the WHO thirth analgesic ladder,
Who cannot join
- cognitive impairment
- psychiatric disease
- illicit drug user
- hypersensitivity to the study drugs
- pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rioko K Sakata
São Paulo
Rioko K Sakata, PhD
About this study
Official title: 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.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Dimorf
Pain Treatment
MethadoneDrug
Also called Mytedom
Pain Treatment
| Study group | Role | What they receive |
|---|---|---|
| Morphine- Methadone | Active comparator | Morphine 5mg/6h plus metadone: 2,5mg/12h Receives: Drug: Morphine; Drug: Methadone |
| Morphine | Active comparator | Morphine: 5mg/6h Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total dose of morphine used by the patient
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start2 Mar 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feliciano Contardo Nepomuceno Duarte, Federal University of São Paulo
- Investigators
- Rioko K Sakata, MD; PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324815
- Sponsor's protocol ID
- 30850414.0.0000.5505
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect Evaluation of Methadone Associated With Morphine for Cancer Pain: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03324815
- Acronym / sponsor ID
- 30850414.0.0000.5505
- Conditions
- Cancer
- Keywords
- Morphine, Methadone, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine- Methadone | Active comparator | Drug: Morphine, Drug: MethadoneMorphine 5mg/6h plus metadone: 2,5mg/12h |
| Morphine | Active comparator | Drug: MorphineMorphine: 5mg/6h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Approved by the Ethics Committee
- signed the informed consent
- cancer pain
- starting the WHO thirth analgesic ladder,
Key exclusion criteria (5 listed)
- cognitive impairment
- psychiatric disease
- illicit drug user
- hypersensitivity to the study drugs
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: DimorfPain Treatment | Drug | Morphine, Morphine- Methadone |
| MethadoneAlso: MytedomPain Treatment | Drug | Morphine- Methadone |
Primary outcome
Opioid consumption
Time frame: 3 months
Total dose of morphine used by the patient
1 secondary outcome
Pain intensity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 34265791Duarte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rioko K Sakata, MD; PhD principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Methadone in people with Cancer, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feliciano NC Duarte, MD (55 11 99265 7272, feliciano.contardo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.