Magnesium Associated With Morphine for Cancer Pain Relief

Not Applicable

Completed

• Conditions: Cancer-related Problem/Condition
• Interventions: Drug: Magnesiun

• Registration Number: NCT01541111
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnesiun, pain relief, sugar pills	Magnesiun	Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h

Primary Outcome Measures

Name	Time	Method
Pain relief	12 wk

Secondary Outcome Measures

Name	Time	Method
Morphine dose	12 wk

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil