Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Rioko K Sakata, MD, PhD
Universidade Federal de São Paulo
Brazil: Ethics Committee