Investigating the effect of vitamin E in the treatment of radiotherapy dermatitis
Design
A controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 56 patients. For randomization, the block random assignment method was used.
Settings and conduct
This project is carried out in Shahid Ramzanzadeh center in Yazd. Patients in two groups of 28 people use zinc oxide cream and vitamin E or zinc oxide twice a day for 4 weeks.
Participants/Inclusion and exclusion criteria
Patients with radiotherapy-induced dermatitis who do not have severe skin disease or systemic disease
Intervention groups
In order to investigate the effectiveness of zinc oxide and topical vitamin E in radiotherapy dermatitis, we gave zinc oxide and topical vitamin E to a group of 28 people and zinc oxide to a group of 28 people.
Main outcome variables
Erythema severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N14
Registration date:2023-10-16, 1402/07/24
Registration timing:retrospective
Last update:2023-10-16, 1402/07/24
Update count:0
Registration date
2023-10-16, 1402/07/24
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Topical vitamin E and zinc oxide versus zinc oxide in treatment of radiation dermatitis: a double-blind clinical trial
Public title
The effect of vitamin E in the treatment of radiotherapy dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 1 to 2 skin dermatitis caused by radiotherapy
Patients aged 18 to 65 years
Exclusion criteria:
Patients with skin disease
hypersensitivity to vitamin E or zinc oxide
Severe systemic disease such as uncontrolled diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 56 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 12 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 56 is in 12 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 56.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received. The patients in the two groups received the medications in the same packaging.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.244
Health conditions studied
1
Description of health condition studied
Dermatitis caused by breast radiation therapy
ICD-10 code
L58
ICD-10 code description
Radiodermatitis
Primary outcomes
1
Description
Intensity of redness
Timepoint
Weeks 0, 1, 2, 3, 4
Method of measurement
RTOG standard scale
2
Description
Itching intensity
Timepoint
Weeks 0,1,2,3,4
Method of measurement
Based on visual analog scale
3
Description
Intensity of burning
Timepoint
Weeks 0,1,2,3,4
Method of measurement
Based on visual analog scale
4
Description
Intensity of pain
Timepoint
Weeks 0,1,2,3,4
Method of measurement
Based on visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient receives topical ointment of vitamin E 18% and zinc oxide 20% (manufactured in Yazd Faculty of Pharmacy) twice daily from the first day of radiation therapy for four weeks.
Category
Treatment - Drugs
2
Description
Control group: The patient receives 20% zinc oxide topical ointment (manufactured in Yazd Faculty of Pharmacy) twice a day from the first day of radiation therapy for four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ramezanzadeh Radiotherapy Center, Yazd
Full name of responsible person
Masood Shabani
Street address
Shahid Mottahari Street, Azadi Sq
City
Yazd
Province
Yazd
Postal code
8917657961
Phone
+98 35 3725 1171
Email
shabanimasood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
8915173143
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.