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: pactr.samrc.ac.za
Trial no.: PACTR201211000432357 Date of Approval: 08/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Musculoskeletal Diseases,Vertebral metasteses
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/10/2012
Actual trial start date 01/10/2012
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date 31/12/2012
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Care giver/Provider,Outcome Assessors,Participants
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 Age Category Minimum age Maximum 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 Year(s) 70 Year(s) 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 13/09/2012 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 Street address
Principal Investigator Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem street
City Postal code Country Position/Affiliation
Tanta 35217 Egypt Assistant professor of Anesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information