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Clinical Trials/NCT01541111
NCT01541111
Completed
Not Applicable

Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief

Federal University of São Paulo1 site in 1 country40 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Magnesiun
Conditions
Cancer-related Problem/Condition
Sponsor
Federal University of São Paulo
Enrollment
40
Locations
1
Primary Endpoint
Pain relief
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
March 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Rioko Kimiko Sakata

PhD

Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Were excluded from the study patients with hypersensitivity to drugs and pregnant

Arms & Interventions

Magnesiun, pain relief, sugar pills

Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h

Intervention: Magnesiun

Outcomes

Primary Outcomes

Pain relief

Time Frame: 12 wk

Secondary Outcomes

  • Morphine dose(12 wk)

Study Sites (1)

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