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.: PACTR202001797822250 Date of Approval: 29/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The early use of steroid therapy in reducing chemotherapy induced myocarditis following cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy in the early post-operative period: A retrospective study
Official scientific title The early use of steroid therapy in reducing chemotherapy induced myocarditis following cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy in the early post-operative period: A retrospective study
Brief summary describing the background and objectives of the trial The aim of the study is to judge the efficacy of the early use of steroid therapy in reducing chemotherapy induced myocarditis following cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy in the early post-operative period versus late use of steroid therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2020
Actual trial start date 01/01/2020
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 30/04/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not 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 randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group late four months collecting data for retrospective study lately when the patient develops acute respiratory distress syndrome solumedrol "Methyl prednisolone sodium succinate" was given with daily chest-X ray and echocardiographic assessment of left ventricular ejection fraction (LVEF) and fractional shortening (LVFS) 30 Active-Treatment of Control Group
Experimental Group Early four months collecting data for retrospective study early solumedrol "Methyl prednisolone sodium succinate" infusion (15 mg/kg/day i.e. 1g/day) for 3 days to guard against acute lung injury ( ALI) and chemotherapy-induced myocarditis together with daily chest-X ray and echocardiographic assessment of left ventricular ejection fraction (LVEF) and fractional shortening (LVFS) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Greater than or equal to 18 years of age. • Clinical performance status of ECOG ≤ 2. • Stable serum CEA levels not indicating recurrence. • No history of prior/other malignancies within the 2 years prior to enrollment with the exception of basal cell carcinoma. • Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery. • Prior experimental therapy with novel agents. • Prior HIPEC. • History of brain metastases. • Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies or with evidence of moderate to severe ascites. • Weight less than 40 kg. • History of congestive heart failure and/or an LVEF < 40%. • Significant COPD or other chronic pulmonary restrictive disease with PFT's indicating an FEV1 less than 50% or a DLCO less than 40% predicted for age. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 17/12/2019 the institutional Review board of the National cancer institute
Ethics Committee Address
Street address City Postal code Country
Fom ELkhalig ,Cairo11796,Egypt Cairo 0020 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome judge the efficacy of the early use of steroid therapy in reducing chemotherapy induced myocarditis following cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy in the early post-operative period. 0ne week postoperative
Secondary Outcome echocardiographic assessment of left ventricular ejection fraction (LVEF) and fractional shortening (LVFS) for all patients. one week postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national cancer institute fom elkhalig cairo 0020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National cancer institute cairo university Fom elkhalig square Kasr el aini street Cairo 0020 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National cancer institute fom elkhalig Cairo Egypt Cairo 0020 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Moustafa Hassan 23 mohsen farid -helwan Cairo 0020 Egypt
Ihab saad 56 ali khalil maadi street Cairo 0020 Egypt
mohamed taher 45 farghaly manial street Cairo 0020 Egypt
suzan adlan 34 mohammed tawfik diab nasr city Cairo 0020 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Hassan rdjxrdj@yahoo.com 01006579954 45 elmokatam st
City Postal code Country Position/Affiliation
Cairo 0020 Egypt National cancer institute
Role Name Email Phone Street address
Principal Investigator Suzan Khedr dr_s.adlan@hotmail.com 01111068300 34 makram ebid nasr city
City Postal code Country Position/Affiliation
Cairo 0020 Egypt National cancer institute
Role Name Email Phone Street address
Public Enquiries Ihab saad drihab2013@gmail.com 01022742244 15 elmanial st
City Postal code Country Position/Affiliation
Cairo 0020 Egypt national cancer institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information