1. Purpose of study: the evaluation of systemic prescriptin of zinc sulphate in prevention of chemotherapy-induced mucositis in patirnts with leukemia. 2. Performing design of study: this 6 month study will be performed in two case & study groups of patients with leukemia refering to oncology ward of Tabriz shahid ghazi hospital. 3. Inclusion criteria: patients within range of 18-71 years old hospitalizing in oncology ward of Tabriz shahid ghazi hospital undergoing chemotherapy due to leukemia. 4. Exclusion criteria: patients who have other systemic diseases; existence of any oral ulcers or mucositis before the beginning chemotherapy; experience of drug sensitivity. 5. Sample size: 140 patients with leukemia would be divided into two equal groups. 6. Interventios case group: zinc sulphate with 220mg/kg dosage would be prescribed during chemotherapy. 7. Intervention time: during chemotherapy. 8. Studied outcomes: The incidence & severity of chemotherapy-induced mucositis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042312510N2
Registration date:2013-08-03, 1392/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Narges Gholizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5968
Email address
n.gholizadeh88@gmail.com
Recruitment status
Recruitment complete
Funding source
Tooth and gingiva diseases research center, Tabriz, Iran
Expected recruitment start date
2013-04-28, 1392/02/08
Expected recruitment end date
2013-09-10, 1392/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of systemic zinc sulphate in prevention of chemotherapy-induced mucositis in patients with leukemia
Public title
Efficacy of systemic zinc sulphate in prevention of chemotherapy-induced mucositis in patients with leukemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients within range of 18-71 years old hospitalizing in oncology ward of Tabriz shahid ghazi hospital(Tabriz, Iran) undergoing chemotherapy due to leukemia. Exclusion criteria: patients who have other systemic diseases; existence of any oral ulcers or mucositis before the beginning chemotherapy; experience of drug sensitivity.
Age
From 18 years old to 71 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Tabriz, Golgasht st, Tabriz university of medical sciences, No 2 central building, 3th floor
City
Tabriz
Postal code
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
9267
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C90.1
ICD-10 code description
Plasmacytic leukemia
Primary outcomes
1
Description
Mucositis
Timepoint
2& 4 weeks after chemotherapy
Method of measurement
Index of WHO
Secondary outcomes
1
Description
Allergy to drug
Timepoint
One day after drug prescription for one month
Method of measurement
Clinical examination
Intervention groups
1
Description
Prescription of zinc sulphate(PO) in case group byoncologist during chemotherapy protocol with 220mg/kg dosage would be performed
Category
Treatment - Drugs
2
Description
prescription of Multivitamin drug(PO) in control group by oncologist during chemotherapy protocol and the once daily for patients would be performed
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid ghazi hospital
Full name of responsible person
Hadi chavoshi
Street address
Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Seid Kazem Shakouri
Street address
Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Narges Gholizadeh
Position
Oral medicine specialist, assistance professor
Other areas of specialty/work
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5968
Fax
Email
n.gholizadeh88@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Chavoshi
Position
Oncology spesialist
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Shahid Ghazi hospital
City
Tabriz
Postal code
Phone
+98 41 1336 2336
Fax
chavoshi-h@yahoo.com
Email
chavoshi-h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Dental Faculty
Full name of responsible person
Sirwan Kahani
Position
Undergraduated student
Other areas of specialty/work
Street address
Golgasht st, Dental faculty
City
Tabriz
Postal code
57819-17193
Phone
+98 44 4422 8857
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)