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Completed

NCT Number: NCT01541111

Magnesium 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.

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Key information

Conditions

Cancer-related Problem/Condition Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Paulo

São Paulo, 04023062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesiun

Drug

75mg pills; each 12h; 12wk

Other names: NMDA receptor antagonist

Primary outcomes

  1. Pain relief

    Time frame: 12 wk

Secondary outcomes

  1. Morphine dose

    Time frame: 12 wk

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 29, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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