A randomized, double-blind, placebo-controlled trial conduct to evaluate the effectiveness of selenium 400 mcg/day in prevention and alleviation of the oral radiotherapy induced mucositis. Patients with oral, nasopharynx or hypopharynx cancer will be enrolled in the study. Patients under 18 years old exclude the study. sample size is at least 30 patients.They will be randomly allocated to receive either selenium or placebo. Patients will be graded on the basis of severity of mucositis on the basis of world health organization classification of mucositis on a weekly basis by using WHO scale for 5 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010511192N4
Registration date:2015-03-15, 1393/12/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Depeuty of Research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of selenium on prevention or alleviation of oral mucositis induced by radiotherapy
Public title
Effect of selenium on oral inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diagnosis of oral;nasopharynx or hypopharynx cancer; who recieve at least 5000 centi gray radiation; at lest 2 locations of oral suitable fior radiotherapy
Exclusion criteria: Patients under 18 years old
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee, Deputy of Reserch, Shahid Beheshti University of Medical Sciences
Street address
Ethics committee, Deputy of Research, Shahid Beheshti University of Medical Sciences, Arabi street, Velenjak