Back to resultsMagnesium Associated With Morphine for Cancer Pain Relief
Primary Purpose
Cancer-related Problem/Condition
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Magnesiun
Sponsored by
About this trial
This is an interventional treatment trial for Cancer-related Problem/Condition focused on measuring Cancer pain, Magnesiun
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
Sites / Locations
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Magnesiun, pain relief, sugar pills
Arm Description
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
Morphine dose
Full Information
NCT ID
NCT01541111
First Posted
February 17, 2012
Last Updated
July 27, 2015
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01541111
Brief Title
Magnesium Associated With Morphine for Cancer Pain Relief
Official Title
Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition
Keywords
Cancer pain, Magnesiun
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesiun, pain relief, sugar pills
Arm Type
Other
Arm Description
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
Intervention Type
Drug
Intervention Name(s)
Magnesiun
Other Intervention Name(s)
NMDA receptor antagonist
Intervention Description
75mg pills; each 12h; 12wk
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
12 wk
Secondary Outcome Measure Information:
Title
Morphine dose
Time Frame
12 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil
12. IPD Sharing Statement
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Magnesium Associated With Morphine for Cancer Pain Relief
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