Magnesium Associated With Morphine for Cancer Pain Relief
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief|
- Pain relief [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
- Morphine dose [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541111
|Universidade Federal de São Paulo|
|São Paulo, Brazil, 04023062|
|Study Director:||Rioko K Sakata, MD, PhD||Universidade Federal de São Paulo|