Magnesium Associated With Morphine for Cancer Pain Relief | NCT01541111

Studies
Magnesium Associated With Morphine for Cancer Pain Relief

NCT01541111

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Jul 28, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Cancer-related Problem/Condition

Interventions

Magnesiun

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 17, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Feb 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesiun, pain relief, sugar pills	Other	Magnesiun 75mg po each 12h pain relief Sugar pills po each 12h	Drug: Magnesiun

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesiun	Drug	75mg pills; each 12h; 12wk	Magnesiun, pain relief, sugar pills

Measure	Description	Time Frame
Pain relief		12 wk

Measure	Description	Time Frame
Morphine dose		12 wk

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rioko K Sakata, MD, PhD	Universidade Federal de São Paulo	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal de São Paulo		São Paulo	São Paulo	04023062	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723621	GluN2C-2D antagonist UBP145

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided