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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Cancer-related Problem/Condition

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Pain relief

Outcome Time Frame:

12 wk

Safety Issue:

No

Principal Investigator

Rioko K Sakata, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Universidade Federal de São Paulo

Authority:

Brazil: Ethics Committee

Study ID:

CEP0153/09

NCT ID:

NCT01541111

Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

  • Cancer-Related Problem/Condition
  • Cancer pain
  • Magnesiun

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