Cancer-related Problem/ConditionNCT01541111
Magnesium Associated With Morphine for Cancer Pain Relief
A study testing Magnesiun in people with Cancer-related Problem/Condition, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer-related Problem/Condition
- What is being tested?
- Magnesiun
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Mar 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After approval by the Ethics Committee and signed informed consent,
- 40 patients, > 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied
Who cannot join
- Were excluded from the study patients with hypersensitivity to drugs and pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.
Read the detailed description
The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged > 18 years of both genders with cancer pain, will be studied.
The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed.
Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk.
The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.
- Conditions
- Cancer-related Problem/Condition
- Being tested
- Magnesiun
- Keywords
- Cancer pain, Magnesiun
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiunDrug
Also called NMDA receptor antagonist
75mg pills; each 12h; 12wk
| Study group | Role | What they receive |
|---|---|---|
| Magnesiun, pain relief, sugar pills | Other | Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h Receives: Drug: Magnesiun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: 12 wk
Secondary outcomes (1)
Morphine dose
Measured: 12 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startJan 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Problem/ConditionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rioko Kimiko Sakata, Federal University of São Paulo
- Investigators
- Rioko K Sakata, MD, PhD, Study director, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541111
- Sponsor's protocol ID
- CEP0153/09
- Status last verified
- Jul 2015
- First submitted
- 17 Feb 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
- ClinicalTrials.gov ID
- NCT01541111
- Acronym / sponsor ID
- CEP0153/09
- Conditions
- Cancer-related Problem/Condition
- Keywords
- Cancer pain, Magnesiun
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Feb 2012 (estimated)
- 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.
This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.
Detailed description
The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged > 18 years of both genders with cancer pain, will be studied.
The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed.
Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk.
The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnesiun, pain relief, sugar pills | Other | Drug: MagnesiunMagnesiun 75mg po each 12h pain relief Sugar pills po each 12h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- After approval by the Ethics Committee and signed informed consent,
- 40 patients, > 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied
Key exclusion criteria (1 listed)
- Were excluded from the study patients with hypersensitivity to drugs and 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 |
|---|---|---|
| MagnesiunAlso: NMDA receptor antagonist75mg pills; each 12h; 12wk | Drug | Magnesiun, pain relief, sugar pills |
Primary outcome
Pain relief
Time frame: 12 wk
1 secondary outcome
Morphine dose
Time frame: 12 wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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 study director
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 Magnesiun in people with Cancer-related Problem/Condition, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 12 wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2015.