Magnesium Associated With Morphine for Cancer Pain Relief

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 23, 2014
Last verified: February 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Analgesic Effect of Magnesiun Associated With Morphine for Cancer Pain Relief

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 12 wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morphine dose [ Time Frame: 12 wk ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541111

Contacts
Contact: Luis G Bahaklini, MD55 11 55 11 80197600 lg.baaklini@gmail.com

Locations
Brazil
Universidade Federal de São Paulo Recruiting
São Paulo, Brazil, 04023062
Contact: Adriana M Issy, PhD    55 11 50847463    issyam.dcir@epm.br   
Sub-Investigator: Luis G Bahaklini, MD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Rioko Kimiko Sakata, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01541111     History of Changes
Other Study ID Numbers: CEP0153/09
Study First Received: February 17, 2012
Last Updated: February 23, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Cancer pain
Magnesiun

ClinicalTrials.gov processed this record on October 29, 2014