Comparison between vitamin E, hyaluronic acid and triamcinolone with triamcinolone mouthwash in radiotherapy induced mucositis
Design
This study was a triple blind clinical trial with the aim of comparing the combination of vitamin E, hyaluronic acid and triamcinolone with triamcinolone mouthwash, and to collect data from a clinical examination and medical records of patients (including: Type of cancer, total radiation dose and number of treatment sessions).
Settings and conduct
Patients with any type of malignant neoplasm referring to Imam Khomeini Hospital, Tehran University of Medical Sciences, who are undergoing radiotherapy in an outpatient setting, will be included in this study.
After diagnosis of Grade 3 and 4 oral mucositis, taking into account the criteria for entering and leaving the study.
Participants/Inclusion and exclusion criteria
Patient entry requirements include: Patients with (at least 18 years of age) (no maximum age limit, Patients with definite cervical cancer diagnosis according to histopathologic examination, Observe oral hygiene in a way that does not prevent the degree of mucositis severity, The patient has the ability to use mouthwash, Grade 3 and 4 oral mucositis according to WHO grade, No history of susceptibility to the drugs studied (so that patients are asked about drug sensitivities prior to entering the study and if they have not a history of hypersensitivity, they are included in the study, Signing consent form inform.ed
Intervention groups
Patients with any type of malignant neoplasm referring to Imam Khomeini Hospital, Tehran University of Medical Sciences, who are undergoing radiotherapy in an outpatient setting, will be included in this study.
Main outcome variables
Failure to tolerate mouthwash is reported by patients, and if the number reaches a significant number of people, the study will be stopped.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190428043407N1
Registration date:2019-07-20, 1398/04/29
Registration timing:registered_while_recruiting
Last update:2019-07-20, 1398/04/29
Update count:1
Registration date
2019-07-20, 1398/04/29
Registrant information
Name
mona pourpasha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 2091
Email address
pourpasha.mona@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy
Public title
Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient entry requirements include: Patients with (at least 18 years of age) (no maximum age limit, Patients with definite cervical cancer diagnosis according to histopathologic examination, Observe oral hygiene in a way that does not prevent the degree of mucositis severity, The patient has the ability to use mouthwash, Grade 3 and 4 oral mucositis according to WHO grade, No history of susceptibility to the drugs studied (so that patients are asked about drug sensitivities prior to entering the study and if they have not a history of hypersensitivity, they are included in the study, Signing consent form informed
Exclusion criteria:
Patient withdrawal criteria from the study include: Pregnant women who recently used (3 weeks) vitamin E and other supplemental antioxidants, Patients with other active oral lesions (such as major asthma), History of alcohol use, Drugs - Performing previous radiotherapy treatments and current chemotherapy treatments and bone marrow transplants with clinical, neurological, endocrine and other systemic diseases. Karnofsky performance status scale less than 60 (Patients in need of admission)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method will be based on the Balanced Block randomization method using the Microsoft Excel software. The number and size of blocks are determined by the individual.
After the random allocation list has been obtained, on the mouthwash package (containing 4 glasses) and on the glass the consecutive numbers (from 1 to the final sample size) are written. A random assignment list is maintained in two versions and in two different locations by the person who generates the random allocation list until the data is analyzed.
Randomization is done by an individual who is independent of the results and is not the beneficiary. The organizer of the plan is responsible for evaluating patients and forcing them to study and allocate interventions to them.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the investigator (executor) responsible for administering interventions and the outcome of the outcome, the patients and the statistical analyzer of which patient are in the intervention group and which control group is not known, and only patient records recorded during the successive weeks 1 to 4 , In the form of groups A and B is provided to the analyzer (Triple Blind).
Placebo
Not used
Assignment
Other
Other design features
The data required for the study are recorded in the forms provided by the moderator. Part of the information will be obtained by asking the patient and examining his case and the other part by the investigator's examination of the patient. Details are listed in the evaluation section of the study outcomes.Regular fast-tracking and daily follow-up through telephone calls increase patient adherence to proper protocol (oral maturation) and more confidence in the outcome. Failure to comply with medical orders of less than 70% and non-compliance with a visit of less than 70% will be considered as a deviation from the protocol. Data will be entered in the SPSS software without name and based on the code of the study. These data are provided to the statistical analyzer after determining whether each person belongs to one of the two groups without knowledge of the intervention or comparison of each group (by third party). * The method of analysis of the basic statistics related to The patient and the characteristics of the disease as well as the variables affecting the outcome of the study (probable confounders) are divided into two groups of study, to evaluate the accuracy of random allocation and the ability to compare the two groups.The percentage of mucositis intensity decreases qualitatively in two groups and will be compared with Chi-square statistical analysis. The severity of pain will be evaluated quantitatively after examining the data distribution with independent t-test or Mann-Whitney test. The frequency of complications in each group is reported by the Chi-square test (or Fisher test). The statistical significance is considered to be less than 0.05. More analyzes are performed after analyzing the primary and secondary consequences for the subgroup analyzes Will decide
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
dental school of tehran university
Street address
End of North Kargar Street, adjacent to the Atomic Energy Organization, High School of Dentistry, Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1439955991
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.043
Health conditions studied
1
Description of health condition studied
Oral mucositis induced by radiotherapy
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
PAIN
Timepoint
weeks1,2,3,4
Method of measurement
Numerical pain scale
2
Description
The rate of improvement in the severity of oral lesions
Timepoint
possible change of oral mucositis grade from 3 and 4 to steady levels
Method of measurement
WHO Grading
3
Description
Type of prescription
Timepoint
weeks 1,2,3,4
Method of measurement
Based on the study method
4
Description
period of time
Timepoint
Date of referral of patients in weeks 1, 2, 3 and4
Method of measurement
Week 1 and 2, 3, and 4 Treatments
5
Description
gender
Timepoint
Date of referral of patients
Method of measurement
observation
6
Description
Age
Timepoint
Date of referral of patients
Method of measurement
Ask the patient
Secondary outcomes
1
Description
Lack of the mouth wash tolerance is noted by patients and the study will be stopped if there are significant numbers of these people.
Timepoint
weeks 1,2,3,4
Method of measurement
ask the patient
Intervention groups
1
Description
Intervention group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by mouthwash contains of vit E , hyaluronic acid and triamcinolone
Category
Treatment - Drugs
2
Description
Control group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by triamcinolone mouthwsh
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
farzaneh aghahoseini
Street address
Tehran Province Tehran Chamran, East, Highway, Baqerkhan St
City
tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Fax
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
farzaneh aghahoseini
Street address
End of North Kargar Street, adjacent to the Atomic Energy Organization, High School of Dentistry, Tehran University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Fax
+98 21 6640 5047
Email
dentistry@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir
Grant name
Faculty of Education
Grant code / Reference number
98-01-70-38775
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
FARZANEH AGHAHOSSEINI
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Fax
+98 21 6640 5047
Email
dentistry@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
FARZANEH AGHAHOSSEINI
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Fax
+98 21 6640 5047
Email
dentistry@tums.ac.ir
Web page address
https://dentistry.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
FARZANEH AGHAHOSSEINI
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, High School of Dentistry, not reaching the exit of Hakim East, next to Atomic Energy Organization, End of North Worker Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Fax
+98 21 6640 5047
Email
dentistry@tums.ac.ir
Web page address
https://dentistry.tums.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 the data collection and completion of the study, the dissertation and the article will be displayed.
When the data will become available and for how long
Until the completion of the data collection
To whom data/document is available
The organizer collects the information plan as blind and analyzer analyses it blind and then By the third person, the results of the study will be specified.
Under which criteria data/document could be used
It will be acceceble in the form of a paper for use and general application.
From where data/document is obtainable
full professor.Dr. Farzaneh aghahoseini
What processes are involved for a request to access data/document
Search in the motor searches
Comments
All of the above will be available upon completion of the research work