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Evaluating the effect of Vitamin E and Vitamin A on Chemotherapy-Induced Oral Mucositis

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History
# Registration date Revision Id
2 2023-12-02, 1402/09/11 287245
1 2022-02-16, 1400/11/27 217151
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  • General information

    Not blinded
    Double blinded
    1
    1
    Not used
    Used
    empty
    40
    empty
    2022-06-22, 1401/04/01
    empty
    2022-10-22, 1401/07/30
    empty
    2022-10-22, 1401/07/30
    empty
    Record the number of samples Changes in study implementation details
    empty
    ثبت تعداد نمونه تغییر در جزئیات اجرا مطالعه
    Participant and Analyzer are blind. Participants were unaware of their group type and Blinding of the participants was done by receiving a placebo identical to the main drug. Analyzes was performed by blind people other than the main researchers.
    شرکت کننده و انالیز کننده کور هستند. شرکت کنندگان از وضعیت گروه خود بی اطلاع بودند و کور سازی شرکت کننده ها از طریق دریافت پلاسبو هم شکل با دارو اصلی انجام شده است. انالیز توسط افراد کور سازی شده غیر از محققین اصلی انجام شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Iranmehr Hospital
    Name of recruitment center - Persian: بیمارستان ایرانمهر
    Full name of responsible person - English: Mohamad Amir Mohamadifard
    Full name of responsible person - Persian: محمد امیر محمدی فرد
    Street address - English: Ghaffari _ Iran Mehr Hospital
    Street address - Persian: غفاری _ بیمارستان ایران مهر
    City - English: Birjand
    City - Persian: بیرجند
    Province: South Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: ۹۷۱۷۸۴۴۴۷۱
    Phone: +98 56 3162 6800
    Fax:
    Email: iranmehr@bums.ac.ir
    Web page address:
    Name of recruitment center - English: Iranmehr Hospital
    Name of recruitment center - Persian: بیمارستان ایرانمهر
    Full name of responsible person - English: Mohamad Amir Mohamadifard
    Full name of responsible person - Persian: محمد امیر محمدی فرد
    Street address - English: Ghaffari, Iran Mehr Hospital
    Street address - Persian: غفاری _ بیمارستان ایران مهر
    City - English: Birjand
    City - Persian: بیرجند
    Province: South Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9717844471
    Phone: +98 56 3162 6800
    Fax:
    Email: iranmehr@bums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Toba Kazemi
    Full name of responsible person - Persian: طوبی کاظمی
    Street address - English: Ghaffari, University of Medical Sciences
    Street address - Persian: غفاری، دانشگاه علوم پزشکی
    City - English: Birjand
    City - Persian: بیرجند
    Province: South Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: ۹۷۱۷۸۵۳۵۷۷
    Phone: +98 56 3238 1200
    Fax:
    Email: drtooba.kazemi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Toba Kazemi
    Full name of responsible person - Persian: طوبی کاظمی
    Street address - English: Ghaffari, University of Medical Sciences
    Street address - Persian: غفاری، دانشگاه علوم پزشکی
    City - English: Birjand
    City - Persian: بیرجند
    Province: South Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9717853577
    Phone: +98 56 3238 1200
    Fax:
    Email: drtooba.kazemi@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effect of vitamin E and A on chemotherapy-induced mucositis
Design
Non Randomized controlled clinical trial with parallel groups, phase 3 study on 28 samples
Settings and conduct
Based on the inclusion criteria, 28 samples of patients of Iran Mehr Birjand Hospital will be selected and will be divided into two groups of intervention and control. From the first day of study , the intervention group will receive vitamin E and vitamin A. All the patients will undergo oral examination on days 1, 7, 14, and 21 to evaluate the severity of the mucositis (according to World Health Organization scale).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Patients undergoing chemotherapy whose course of chemotherapy does not interaction with vitamins A and E. Exclusion criteria: 1.Using alcohol or cigarette
Intervention groups
Intervention group: Patients will receive vitamin E and vitamin A daily in 4 day period . Control group: will not receive any vitamin E and vitamin A
Main outcome variables
Oral mucositis

General information

Reason for update
Record the number of samples Changes in study implementation details
Acronym
IRCT registration information
IRCT registration number: IRCT20210916052498N1
Registration date: 2022-02-16, 1400/11/27
Registration timing: prospective

Last update: 2023-12-03, 1402/09/12
Update count: 1
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
Hossein Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 8707
Email address
gholami.g76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
2022-06-22, 1401/04/01
Actual recruitment end date
2022-10-22, 1401/07/30
Trial completion date
2022-10-22, 1401/07/30
Scientific title
Evaluating the effect of Vitamin E and Vitamin A on Chemotherapy-Induced Oral Mucositis
Public title
Evaluating the effect of Vitamin E and Vitamin A on Chemotherapy-Induced Oral Mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Chemotherapy’s indicated No interactions between vitamins E and A and chemotherapy
Exclusion criteria:
Chemotherapy’s Contraindicated Interactions between vitamins E and A and chemotherapy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 28
Actual sample size reached: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and Analyzer are blind. Participants were unaware of their group type and Blinding of the participants was done by receiving a placebo identical to the main drug. Analyzes was performed by blind people other than the main researchers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ghaffari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2022-01-18, 1400/10/28
Ethics committee reference number
IR.BUMS.REC.1400.322

Health conditions studied

1

Description of health condition studied
Oral Mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy

Primary outcomes

1

Description
Oral Mucositis
Timepoint
Days 1, 7, 14 and 21 after starting cancer treatment
Method of measurement
Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.

Secondary outcomes

1

Description
Pain severity
Timepoint
Days 1, 7, 14 and 21 after starting cancer treatment
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group: patients receive vitamin E (100 mg/day) and vitamin A (25000 Unit/day) for 4 days .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranmehr Hospital
Full name of responsible person
Mohamad Amir Mohamadifard
Street address
Ghaffari, Iran Mehr Hospital
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6800
Email
iranmehr@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Ghaffari, University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohamad Amir Mohamadifard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Ghaffari _ Iran Mehr Hospital
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6800
Email
mohamadamir_mohamadifard@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Leili Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran _ School of Dentistry
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
alizadeh۱۳۶۴۲۰۰۱@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Gholami
Position
Collegian
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.10 montazeri8 montazeri street
City
Birjand
Province
South Khorasan
Postal code
9714713361
Phone
+98 56 3222 8707
Email
gholami.g76@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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