Almost all (90-97%) of patients undergoing head and neck radiation therapy alone or in combination with chemotherapy are being developed mucositis, among which 30% will experience severe mucositis. These complications can lead to treatment interruption or discontinuation of it, at all. So cancer mortality rate will increase. This Study aims to reduce the incidence and severity of mucositis in patients receiving radio chemotherapy by taking selenium supplements. Patients over 18 years with head and neck carcinoma that candidate for radio chemotherapy , normal renal and liver function and no history of using selenium supplements were randomly assigned to either the intervention group (receiving selenium tablets) and control group (Placebo similar to selenium tablets). In this randomized, double-blind, placebo-controlled clinical trial, 84 patients whose meat inclusion criteria were assigned to control and intervention group randomly. Patients in intervention group use selenium 200 milligrams tablets twice daily and control group consumption two placebos per day from the beginning of treatment with radiation by the end of radio chemotherapy sessions. Selenium blood level prior to starting radiotherapy and after treatment completion is measured in all patients. Well as the incidence and severity of mucositis in these patients is measured weekly during drug consumption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072718612N1
Registration date:2016-10-07, 1395/07/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-07, 1395/07/16
Registrant information
Name
Elahe Laali
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 6465
Email address
e_laali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Selenium on incidence and severity of mucositis in head and neck cancer patients undergoing radio chemotherapy
Public title
Selenium in radiochemotherapy mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:age over 18 years old;head and neck carcinoma ;radiocemotherapy candidate;liver and kidney normal condition;at least two third of oral cavity is exposed radiotherapy
exclusion criteria:under 18 years old;prior history of using selenium;kidney and hepatic failure
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Tehran University of Medical Science
Street address
Tehran University of Medical Science, 16 Azar street, Keshavarz blv
City
Tehran
Postal code
Approval date
2014-09-21, 1393/06/30
Ethics committee reference number
93-02-156-26220-123953
Health conditions studied
1
Description of health condition studied
Malignant melanoma of other and unspecified parts of face
ICD-10 code
C43.3
ICD-10 code description
Malignant melanoma of other and unspecified parts of face
2
Description of health condition studied
Malignant neoplasm of nasal cavity and middle ear
ICD-10 code
C30
ICD-10 code description
Malignant neoplasm of nasal cavity and middle ear
3
Description of health condition studied
Malignant neoplasm of accessory sinuses
ICD-10 code
C31
ICD-10 code description
Malignant neoplasm of accessory sinuses
4
Description of health condition studied
Malignant neoplasm of larynx
ICD-10 code
C32
ICD-10 code description
Malignant neoplasm of larynx
5
Description of health condition studied
Malignant melanoma of lip
ICD-10 code
C43.0
ICD-10 code description
Malignant melanoma of lip
Primary outcomes
1
Description
mucositis
Timepoint
7days after interventionn and then weekly and 7 days after finshing intervention
Method of measurement
Physical examination
2
Description
selenium blood level
Timepoint
prior of radiation start and at the end of radiotherapy sessions
Method of measurement
Spectrophotometry
3
Description
Neutropenia
Timepoint
prior of selenium start and at the end of radiotherapy sessions
Method of measurement
blood level
4
Description
mucositis length
Timepoint
7days after interventionn and then weekly and 7 days after finshing intervention
Method of measurement
observation
Secondary outcomes
1
Description
npo(non per oral) time
Timepoint
7 days after intervention and then weekly
Method of measurement
Physical examination
2
Description
narcotic use
Timepoint
weekly
Method of measurement
observation
3
Description
weight
Timepoint
prior and at the end of selenium use
Method of measurement
kg
Intervention groups
1
Description
intervention group:
Tab selenium 200 mg twice daily during radiotherapy
Category
Treatment - Drugs
2
Description
control group: two placebo tablets per day during radiotherapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Elahe Laali
Street address
Keshavarz blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Rational Drug Use
Full name of responsible person
Dr.M.Hajibabai
Street address
number 2,13 Aban building Karimkhan street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Rational Drug Use
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
Faculty of Pharmacy
Full name of responsible person
Elahe Laali
Position
Pharmacotherapy Resident
Other areas of specialty/work
Street address
Tehran University of Medical Science,16 Azar street, Keshavarz blv
City
Teharn
Postal code
Phone
+98 21 2293 6465
Fax
Email
elahe_laali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy
Full name of responsible person
Zahra Jahangard
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Hospital
City
Tehran
Postal code
Phone
+98 21 6659 3801
Fax
Email
zjahangard@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Elahe Laali
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 2293 6465
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)