History
# Registration date Revision Id
1 2018-10-12, 1397/07/20 62771
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluation of the effect of using and not using (Control) of vitamin E on the oral mucositis caused by head and neck radiotherapy at radiotherapy ward of Imam Hussein hospital in 2017-2018
Design
clinical trial with control group,with parallel groups, Double blind, stratified randomized, Sample size: 24
Settings and conduct
The study is a clinical trial that all patients who have radiotherapy indications who referred to Imam Hussein hospital's radiotherapy department at the time of the study and who have expressed their written consent to participate in the study. Patients were randomly assigned to case group, which received 200mg oral vitamin E daily and placebo for control group. Patients are monitored during the use of drugs and after several days, a clinical examination will be performed, the patient and the weekly assessor are unaware of the patient's treatment group .For examination oral cavity is divided into 12 hypothetical areas by the Epstein method and his partners and according to the second version of the CTC-NCI scoring, the intensity of mucositis in each area is scored. Then the average value will be obtained. Patients are examined on a weekly basis for 8 weeks from the start of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Patients with radiotherapy indication of at least 50Gy throughout the entire study and at least two areas in the field of radiotherapy from the mouth involved in the tumor. Exclusion criteria are: oral mucositis, diabetes, candidiasis, do not consume tobacco.
Intervention groups
Intervention group: Vitamin E, control group: Placebo
Main outcome variables
Oral mucositis severity

General information

Acronym
IRCT registration information
IRCT registration number: IRCT20180924041119N1
Registration date: 2018-10-12, 1397/07/20
Registration timing: registered_while_recruiting

Last update: 2018-10-12, 1397/07/20
Update count: 0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Arash Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0925
Email address
elhp@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin E on prevention of oral mucositis in patients undergoing head and neck radiotherapy
Public title
Effect of vitamin E on Prevention of oral inflammation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have a radiotherapy indication of at least 50Gy throughout the study At least two areas in the radiotherapy field from mouth are involved the tumor
Exclusion criteria:
Patients with diabetes Patients with Candidiasis Patients who use tobacco.
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are stratified randomized, so that patients who are included in the study are stratified in terms of age above 50 years of age and of possible chemotherapy at the same time as radiotherapy. Randomization was performed by a 4‑block stratified technique.
Blinding (investigator's opinion)
Double blinded
Blinding description
Although patients are aware of the study and are given written consent, they are unaware of the fact that the medication is effective or placebo. Also, the controlling person, who examines patients for follow up from the beginning to the end of the study at the hospital, is unaware of which patient is in what group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad Universty of Tehran Medical Sciences
Street address
No. 4, Neyestan 10, Pasdaran st, Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.IAU.TMU.REC.1397.026

Health conditions studied

1

Description of health condition studied
Prevention of oral mucositis caused by head and neck radiotherapy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of Vitamin E Preventional Effects on Oral Mucositis
Timepoint
At the beginning of the study (before the intervention) and 7, 14, 21, 28, 35, 42, 49 and 56 days after the start of taking the drug and placebo
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vitamin E, a daily dose of 200 mg, manufactured by the Dana Pharmaceutical Company,it is prescribed from first session of radiotherapy to 8 weeks.
Category
Prevention

2

Description
Control group: Placebo, in the same color and size as the original drug, was produced by the Dana Company and it has used in the same manner.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Elham Hosseinpour
Street address
Madani st, Imam Hossein Square, Nezam Abad
City
Tehran
Province
Tehran
Postal code
0000000
Phone
+98 21 7343 2338
Fax
+98 21 7755 7069
Email
info@ehmc.ir
Web page address
http://ehmc.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid
Street address
Khaghani st, Shariati st,
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
pezeshkitehran.8@gmail.com
Web page address
http://iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University of Tehran Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Neyestan 9, Pasdaran st
City
Tehran
Province
Tehran
Postal code
1958517511
Phone
+98 21 2258 0925
Email
drarashazizi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Neyestan 9, Pasdaran st
City
Tehran
Province
Tehran
Postal code
1958517511
Phone
+98 22580925
Email
drarashazizi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Hosseinpoor
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.9, Neyestan 9, Pasdaran st
City
Tehran
Province
Tehran
Postal code
1958517511
Phone
+98 21 2248 2251
Email
ehp1390@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Will not be published
When the data will become available and for how long
None
To whom data/document is available
No one
Under which criteria data/document could be used
Unauthorized
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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