Evaluation of the Effectiveness of Mouthwash "Soluble Dexamethasone in AlMg Syrup" in Radiotherapy and Chemotherapy-induced Oral Mucositis in Cancer Patients
The main purpose of this study is to evaluate the efficacy of local dexamethasone on Radiotherapy and Chemotherapy-induced oral mucositis.
Design
Two arm parallel group randomised trial with postoperative care and outcome assessment
Settings and conduct
This study is conducted in Omid research treatment center of Isfahan. Patients are examined and selected during the days of admission to the hospital, and the evidence is recorded and they are followed in four weeks.
Participants/Inclusion and exclusion criteria
Eighty patients is enrolled in the study:40 patients in interval and 40 patients in control group.Eligibility criteria:People undergoing chemotherapy or radiotherapy for cancer;They have oral mucositis (grade 2 or 3) as a result of treatment complications; There are three to four weeks left in their treatment. Exclusion criteria: Patient dissatisfaction; Patient non-cooperation.
Intervention groups
group 1:Dexamethasone Mouthwash group, In order to keep Dexamethasone on the wounds, it was given to the patients as a solution in AlMg syrup(4 ampoules of Dexa in a bottle of syrup). The patients should rinse their mouths every 8 h, after meals,for 30s with 10 ml(A tablespoon) from mouthwash and avoid eating and drinking for half an hour.
group 2:control group,There is no intervention in this group and during their treatment in the hospital, they are followed and monitored for their oral mucositis.
Main outcome variables
Grade of mucositis; Visual Analogue Scale number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220528055004N1
Registration date:2022-07-21, 1401/04/30
Registration timing:registered_while_recruiting
Last update:2022-07-21, 1401/04/30
Update count:0
Registration date
2022-07-21, 1401/04/30
Registrant information
Name
mohammad reza salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3630 2913
Email address
salehi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Mouthwash "Soluble Dexamethasone in AlMg Syrup" in Radiotherapy and Chemotherapy-induced Oral Mucositis in Cancer Patients
Public title
Effect of Dexamethasone Mouthwash in Oral Mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People undergoing Chemotherapy or Radiotherapy for Cancer
They have Oral Mucositis as a Result of Treatment Complications
There are three to four Weeks left in their Treatment
Exclusion criteria:
Patient dissatisfaction
Patient non-cooperation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, Flip the Coin.Based on this, each patient will be placed in one of the two groups after a coin flip.In this way, if the result of flipping a coin is heads, they are included in the control group, and if it is tails they are included in the mouthwash group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 34 , Block c , Zayanderud building , In front of Najvan entrance , Sohrvardi square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۵۷۹۴۹۶۰
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.092
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
Grade of mucositis
Timepoint
The beginning of the study(Before intervention),7,14and 21 days after the starting
Method of measurement
In-person examination and registration based on World Health Organization's mucositis grading scale and Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexamethasone Mouthwash group, In order to keep Dexamethasone on the wounds, it was given to the patients as a solution in AlMg syrup(4 ampoules of Dexa in a bottle of syrup). The patients should rinse their mouths every 8 h, after meals,for 30s with 10 ml(A tablespoon) from mouthwash and avoid eating and drinking for half an hour
Category
Treatment - Other
2
Description
Control group:There is no intervention in this group and during their treatment in the hospital, they are followed and monitored for their oral mucositis
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Mehran Sharifi
Street address
Farshadi Alley, Khayam St
City
Isfahan
Province
Isfehan
Postal code
8184917534
Phone
+98 31 3235 0210
Email
omid@mui.ac.ir
Web page address
http://omid.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
No. 4; Isfahan University of Medical Sciences ; Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data and study documentation, such as non-identifiable data and the outcome of interventions, work methods and ... are collected in the form of thesis.In Shahrivar 1401, this information will be presented during a lecture and then it sent to scientific journals for public use
When the data will become available and for how long
The beginning of the access period is from 1402
To whom data/document is available
This information will be accessible to all interested parties.
Under which criteria data/document could be used
1) In order to increase awareness and improve approaches related to treatment and prevention in the field of research
2)To be presented to medical centers and used in treatment protocols
3)For use in research studies
From where data/document is obtainable
1)Dentistry library of the Isfahan University of Medical Sciences, persian theses section, to the website: http://elib.mui.ac.ir/faces/search
2) Send email to: leily.er@gmail.com
salehi@dnt.mui.ac.ir
3)Search in scientific databases
What processes are involved for a request to access data/document
Search title in the scientific databases and the said site or send email to the email addresses and request