This study has been designed to evaluate the effect of zinc Sulphate in prevention of chemotherapy-induced mucositis. A total of 50 patients with chemotherapy-induced mucositis are randomly assigned into intervention or control group. The intervention group received three zinc sulfate capsules daily (220-mg made by Alhavi Co.) in addition to conventional mucositis treatment and the control group received three placebo capsules daily. for 6 months. Intensity of Mucositis, Xerostomia, and pain are evaluated a week before initiation of chemotherapy, during chemotherapy phase until two weeks after the end of chemotherapy phase, once a week compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101023133N3
Registration date:2011-02-01, 1389/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-01, 1389/11/12
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of zinc sulfate effect in prevention of
chemotherapy-induced mucositis in Patients with cancer referred to Emam Ali Hospital in 2008-2009
Public title
Evaluation of zinc sulfate effect in prevention of
chemotherapy-induced mucositis in Patients with cancer referred to Emam Ali Hospital in 2008-2009
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: chemotherapy treatment with a regimen that had the same mucositis probability, Karnovsky performance status case equal or more than 60, life expectancy equal to or more than 6 months, White Blood Cell count equal to or more than 1500 and platelet count equal to or more than 100000/μL
Exclusion criteria: radiotherapy in the head and neck region, including nasopharynx, oropharynx, and larynx previously or simultaneously, previous head and neck surgery due to malignancy, use of dentures, pregnancy, infection
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Pardis, Zahedan
City
Zahedan
Postal code
Approval date
2010-12-29, 1389/10/08
Ethics committee reference number
89-2870
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced mucositis
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Mucositis
Timepoint
Two weeks after initiation of chemotherapy and every two weeks until
Method of measurement
The patients are examined under a headlight, using dental explorers and mirrors. Data were recorded. Oral mucositis patients were labelled from 0 to 4 ,using World Health.
Secondary outcomes
1
Description
Pain
Timepoint
Two weeks after initiation of chemotherapy and every two weeks untilthe end of chemotherapy phase
Method of measurement
The patients are examined under a headlight, using dental explorers and mirrors. Data were recorded. Oral mucositis patients were labelled from 0 to 4 ,using World Health.
2
Description
Xerostomia
Timepoint
Two weeks after initiation of chemotherapy and every two weeks untilthe end of chemotherapy phase
Method of measurement
The patients are examined under a headlight, using dental explorers and mirrors. Data were recorded
3
Description
Quality of life
Timepoint
Two weeks after initiation of chemotherapy and every two weeks untilthe end of chemotherapy phase
Method of measurement
Quality of life a questionnaire(EORTC LQ-OES18) is filled out each meeting individually by the dental student
Intervention groups
1
Description
Control group/Placebo: three
placebo capsules daily (Alhavi Co.), initiation of chemotherapy until the end of chemotherapy phase.
Category
Prevention
2
Description
Intervention group/Drug: three 220-mg zinc sulfate capsules daily (Alhavi Co.), initiation of chemotherapy until the end of chemotherapy phase
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Emam Ali Hospital
Full name of responsible person
Fateme Arbabi-kalati(assistant of professor ,a specialist of oral medicine)
Street address
Emam Ali Hospital-Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr sagheb (Vice-chancellor for Research, Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Pardis, Khalij Fars Boulevard, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Marzie Deghatipour
Position
Dental student
Other areas of specialty/work
Street address
Faculty of Dentistry, Koye Tirandazi Street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 4004
Fax
Email
marzie_deghatipour@yahoo.com
Web page address
www.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Dr Fateme Arbabi-kalati
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Faculty of Dentistry, Koye Tirandazi Street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 4004
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
www.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Fateme Arbabi-kalati
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Faculty of Dentistry, Koye Tirandazi street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 4004
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
www.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)