Trials / Completed
CompletedNCT01541111
Magnesium Associated With Morphine for Cancer Pain Relief
Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Magnesiun | 75mg pills; each 12h; 12wk |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2012-02-29
- Last updated
- 2015-07-28
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01541111. Inclusion in this directory is not an endorsement.