Magnesium Associated With Morphine for Cancer Pain Relief

Cancer-related Problem/Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541111
• Other study ID #: CEP0153/09
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: July 27, 2015
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer-related Problem/Condition

Intervention

Drug:
• Magnesiun
75mg pills; each 12h; 12wk

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief		12 wk	No
Secondary	Morphine dose		12 wk	No