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Magnesium Associated With Morphine for Cancer Pain Relief

This study is currently recruiting participants.
Verified March 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01541111
First received: February 17, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes

February 17, 2012
March 11, 2013
January 2011
June 2013   (final data collection date for primary outcome measure)
Pain relief [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01541111 on ClinicalTrials.gov Archive Site
Morphine dose [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Magnesium Associated With Morphine for Cancer Pain Relief
Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief

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

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cancer-related Problem/Condition
Drug: Magnesiun
75mg pills; each 12h; 12wk
Other Name: NMDA receptor antagonist
Magnesiun, pain relief, sugar pills
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
Intervention: Drug: Magnesiun
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Luis G Bahaklini, MD55 11 55 11 80197600 lg.baaklini@gmail.com
Brazil
 
NCT01541111
CEP0153/09
No
Rioko Kimiko Sakata, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
Federal University of São Paulo
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP