Protocol summary

Study aim
Determining the Effect of Folic Acid Mouthwash on Prevention of Stomatitis in Patients Under Head and Neck Radiotherapy. ________________________________________
Design
Clinical trials with control and intervention group, with parallel and randomized groups.
Settings and conduct
This study was conducted in the Radiotherapy section of Imam Reza Hospital in Mashhad
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study, lack of immunosuppression and absence of leukocyte and leukocytosis, aged 18 to 60 years, lack of underlying disease (diabetes, kidney disease, liver disease), oral mucosa, and mucosal lesions, The daily intake of external radiation therapy with a dose of 200-180(cGary) for one hour, does not have a history of smoking in a recent month; the lack of simultaneous use of chemotherapy with radiation therapy during the study, lack of sedative, non-use of mouthwash and other medication for Oral ulceration during research, lack of artificial teeth,death, any complications that occur during the study and not able to participate in the study, fever above 38.3 ° C, lack of willingness to continue cooperation in the study, more Do not get 20% mouthwashes during the study
Intervention groups
Combined folic acid solution containing folic acid = 100 mg, NaHCO3=38 mg, propyl parahydroxybenzoate = 25 mg, methyl parahydroxy benzoate = 50 mg, conc peppermint water= 2 ml, distilled water = Up to 100 ml volume) for 14 days at two times in the morning and at night for one minute and then routine mouthwash (magic) with a 15 minute interval and control group 2 times with a distance of more than 15 minutes in two turns In the morning and at night, routine mouthwash is used.
Main outcome variables
Severity of stomatitis، Severity of pain caused by stomatitis، Incidence of oral ulcers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180526039847N1
Registration date: 2019-06-19, 1398/03/29
Registration timing: retrospective

Last update: 2019-06-19, 1398/03/29
Update count: 0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Zahra Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
gholamiz932@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
2018-08-05, 1397/05/14
Actual recruitment end date
2019-03-05, 1397/12/14
Trial completion date
2019-03-05, 1397/12/14
Scientific title
The effect of folic acid mouthwash solution in prevention of head and neck radiotherapy –induced stomatitis
Public title
The Effect of Folic Acid Mouthwash on Stomatitis Caused by Head and Neck radiotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfied to participate in the study The mucous membrane is healthy and free from mucosal lesions and oral and dental problems Age of 18 to 60 years Receive external radiotherapy and radiation at a dose of 180 CGy per day for one hour During the study, do not use any mouthwash and other medication for oral ulcers Not having dentures
Exclusion criteria:
Having immunodeficiency disease and having leukopenia and leukocytosis Having underlying illness (diabetes, kidney disease, liver disease) There is a history of tobacco use, including smoking, hookah, and narcotics in the last month Chemotherapy drugs receive simultaneous radiotherapy during the study Receives sedative During the study, do not use any mouthwash and other medication for oral ulcers
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table with 0-9 assignment to two groups of intervention and control, then on the random numbers table, set the starting point to blinded and specify the sequences of the sequence of the group on the random numbers of the starting point with a blind eye And sequences of sequence numbers of the intervention and control group are determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Mouthwashes of folic acid and magic in similar containers and dividing the dishes into two groups (a, b) and delivering mouthwash to the patients by clinical care will not be known to the researcher in the relationship to the type of mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Crossroad of the Doctora., Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2017-11-24, 1396/09/03
Ethics committee reference number
IR.MUMS.REC.1396.292

Health conditions studied

1

Description of health condition studied
Stomatitis caused by radiotherapy for head and neck
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)

Primary outcomes

1

Description
The incidence of stomatitis
Timepoint
Before the start of the first and seventh and fourteenth days of Radiotherapy, the incidence of stomatitis, pain, mouth ulcers in patients' records.
Method of measurement
The World Health Organization standard tool for measuring stomatitis, pain visual analog scale (Visual Analogue Scale), measuring instruments sores (oral mucositis assessment scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Combined folic acid solution containing (folic acid = 100 mg, NaHCO3=38 mg, propyl parahydroxybenzoate = 25 mg, methyl parahydroxy benzoate = 50 mg, conc peppermint water= 2 ml, distilled water = Up to 100 ml volume)(This mucosal formulation has been used in several cases for gingivitis, which was developed and used by the pharmacist's professor at the Pharmacy Lab of Mashhad University of Medical Sciences for this study) and each time 5 cc for 14 days in Garnish two minutes in the morning and at night and then routine mouthwash (Magic) at 15 minutes intervals. and they do not eat anything until 15 minutes later.
Category
Prevention

2

Description
Control group: The routine oral mucosal control group (magic) with the combination (Aluminum MGS syrup, diphenhydramine syrup, lidocaine ampoules, dexamethasone ampoules, nystatin drops) 2 times more than 15 minutes for 14 days, twice a day for one minutes and they do not eat anything until 15 minutes later. The mouths of patients are examined on the first, seventh and fourteenth days.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Educational Research Center
Full name of responsible person
Seyyed Mousa Mahdizadeh
Street address
Imam Reza Square Imam Reza Educational Research Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Mashhad., next to Hivizadeh Cinema., Mashhad University of Medical Sciences., Deputy of Research & Technology University
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
+98 51 1882 3251
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Mousa Mahdizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Mashhad Crossroad of the Doctora., Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyyed Mousa Mahdizadeh
Position
Faculty of Nursing and Midwifery, Mashhad
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Crossroad of the Doctora., Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 1511
Email
MahdizadehM@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra Gholami
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Crossroad of the Doctora., Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3601 7651
Email
Gholamiz932@mums.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
Only the original outcome information
When the data will become available and for how long
Starting the access period from 1399
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analysis of delivered data is allowed
From where data/document is obtainable
Zahra gholami Gholamiz932@mums.ac.ir
What processes are involved for a request to access data/document
In less than one month, information is provided to the applicant by email.
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