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Magnesium Associated With Morphine for Cancer Pain Relief

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541111
First Posted: February 29, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
  Purpose
This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

Condition Intervention
Cancer-related Problem/Condition Drug: Magnesiun

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief

Further study details as provided by Rioko Kimiko Sakata, Federal University of São Paulo:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 12 wk ]

Secondary Outcome Measures:
  • Morphine dose [ Time Frame: 12 wk ]

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Magnesiun, pain relief, sugar pills
Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h
Drug: Magnesiun
75mg pills; each 12h; 12wk
Other Name: NMDA receptor antagonist

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541111


Locations
Brazil
Universidade Federal de São Paulo
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
  More Information

Responsible Party: Rioko Kimiko Sakata, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01541111     History of Changes
Other Study ID Numbers: CEP0153/09
First Submitted: February 17, 2012
First Posted: February 29, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Rioko Kimiko Sakata, Federal University of São Paulo:
Cancer pain
Magnesiun

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents