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.: PACTR201503001039326 Date of Approval: 18/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nigella sativa seeds and Febrile Neutropenia
Official scientific title Effect of Nigella sativa seed administration on prevention of Febrile Neutropenia during chemotherapy among children with Brain Tumors attending the Pediatric oncology unit in Alexandria Main University Hospital.
Brief summary describing the background and objectives of the trial nigella sativa is known for its antibacterial effect and was tested for being immunomodulatory in a number of invitro and animal trials. Febrile neutropenia is a serious side-effect of chemotherapy that maybe fatal if not managed appropriately and in time.a number of prophylactic antibacterials were given to cancer patients in order to avoid Febrile neutropenia, however this caused emergence of bacterial resistence. as a result, we are testing the effect of administration of a natural product (nigella sativa seeds)on preventing the incidence of febrile neutropenia and subsequent admissions to hospital in addition to the length of hospital stay, in case of admission, in order to improve patients'outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied brain tumors,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2014
Actual trial start date 01/04/2014
Anticipated date of last follow up 01/03/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation Numbered containers Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group effect of nigella sativa seed administration on prevention of febrile neutropenia throughout chemotherapy treatment period controls are not given any kind placebo but their data is collected on follow up as experimental group 40 Active-Treatment of Control Group
Experimental Group effect of nigella sativa seed administration on prevention of Febrile Neutropenia 5gms daily throughout chemotherapy treatment till end of study parents of patients were asked to add 5 gms of nigella sativa seeds onto their childrens' food throughout the day in order to consume the required dose on daily basis and their data and CBC and toxicities, if any, are recorded on each follow-up.. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children (2-18)years with primary brain tumors. 1. children with any type of cancer other than brain tumors. 2. children with relapsed brain tumors. 2 Year(s) 18 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 01/04/2014 ethics committee of High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
65 st., AlHoreya road Alexandria NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevention of febrile neutropenia during chemotherapy cycles in between chemotherapy cycles.
Primary Outcome number of admissions to hospital as a result of febrile neutropenia. in case of occurrence of a febrile neutropenia episode in between chemotherapy cycles.
Primary Outcome Length of hospital stay upon admission as a result of Febrile Neutropenia. in between chemotherapy cycles in case a patient was admitted to hospital due to febrile neutropenia.
Secondary Outcome improvement of chemotherapy-related haematological and GIT toxicities On every time the patient appears for follow-up in between chemotherapy cycles.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pediatric oncology unit - Alexandria university main hospital champollion street - Khartoum square-Azareeta medical campus Alexandria 19731 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal funding 14 mohammed saleh harb Alexandria NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor high institute of public health 65St., AlHoreya road Alexandria NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
none
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hebatullah Moussa drheba_fmoussa@yahoo.com 00201115144443 14- mohammed saleh harb street
City Postal code Country Position/Affiliation
alexandria na Egypt
Role Name Email Phone Street address
Public Enquiries Hebatullah Moussa drheba_fmoussa@yahoo.com 00201115144443 14- mohammed saleh harb street
City Postal code Country Position/Affiliation
alexandria na Egypt
Role Name Email Phone Street address
Scientific Enquiries Hebatullah Moussa drheba_fmoussa@yahoo.com 00201115144443 14- mohammed saleh harb street
City Postal code Country Position/Affiliation
alexandria Egypt
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