Magnesium Associated With Morphine for Cancer Pain Relief
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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 |
- Pain relief [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
- Morphine dose [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
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| Contact: Luis G Bahaklini, MD55 11 | 55 11 80197600 | lg.baaklini@gmail.com |
| 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 | |
| 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: | March 11, 2013 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Cancer pain Magnesiun |
Additional relevant MeSH terms:
|
Morphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 13, 2013