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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201211000432357 Date registered: 2012/10/08
TRIAL DESCRIPTION
Public title Value of methylprednisolone infusion in patients wtih vertebral deposits
Official scientific title Pre-emptive value of methylpredinsolone intravenous infusion in patients with vertebral deposits. Double blinded randomized study
Brief summary describing the background
and objectives of the trial
One hundred twenty patients with vertebral metastases received short course external beam radiotherapy as high-voltage radiation with 6-Mev-Linear-Accelerator , 60 patients received in addition to the short course radiotherapy preemptive methylprednisolone infusion 5 mg/kg the day just before initiation of radiotherapy (grp1) and another 60 patients received short course radiotherapy without pretreatment methylprednisolone infusion (grp2). Brief Pain Inventory (BPI),incidence of pain flare duri
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 2012-10-01
Actual trial start date 2012-10-01
Anticipated date of last follow up 2012-12-31
Actual date of last follow up 2012-12-31
Anticipated target sample size (number of participants) 120   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Preemptive methylprednisolone 5mg/kg 5 days before radiotherapy Once ove 24 hours 60
Control group Placebo 5mg/kg 5 days before radiation 60 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
: One hundred twenty patients with class I-III Harrington classification of vertebral metastases included in the study admitted to the oncology department Patients with any medical contraindications to corticosteroids, such as diabetes mellitus, uncontrolled hypertension, infection, thrombo-embolic disorders or active peptic ulcer were excluded from the study. Patients with a pathological fracture at the irradiated site, patients with other bone metastases and patients with visceral metastases at the time of radiotherapy were also excluded from the study. 18 Years 70 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2012/09/13 Faculty of medicine , Tanta University
Ethics Committee Address
Street address City Postal code Country

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain (VAS) Every two weeks
Secondary Outcome Motor function two weeks
Secondary Outcome Sensory function two weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine. Tanta University Elguish street Tanta Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
s

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor a University

COLLABORATORS
Name Street address City Postal code Country
Nehal Mohamed El-mashad Saed street Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 002010403318113
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem street Tanta 35217 Egypt Assistant professor of Anesthesia