Magnesium Associated With Morphine for Cancer Pain Relief
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|ClinicalTrials.gov Identifier: NCT01541111|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Problem/Condition||Drug: Magnesiun||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Magnesiun, pain relief, sugar pills
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
75mg pills; each 12h; 12wk
Other Name: NMDA receptor antagonist
- Pain relief [ Time Frame: 12 wk ]
- Morphine dose [ Time Frame: 12 wk ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541111
|Universidade Federal de São Paulo|
|São Paulo, Brazil, 04023062|
|Study Director:||Rioko K Sakata, MD, PhD||Universidade Federal de São Paulo|