Protocol summary
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Study aim
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Comparison between vitamin E, hyaluronic acid and triamcinolone with triamcinolone mouthwash in radiotherapy induced mucositis
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Design
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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).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Some dates need updating. Due to the termination of the trial, the exact termination date can be recorded. Also, the expected start and the exact date of starting the trial were postponed until the end of the IRCT registration process.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190428043407N1
Registration date:
2019-07-20, 1398/04/29
Registration timing:
prospective
Last update:
2020-10-03, 1399/07/12
Update count:
1
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Registration date
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2019-07-20, 1398/04/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-23, 1398/05/01
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Expected recruitment end date
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2019-10-23, 1398/08/01
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Actual recruitment start date
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2019-07-23, 1398/05/01
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Actual recruitment end date
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2019-12-06, 1398/09/15
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Trial completion date
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2020-01-06, 1398/10/16
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Scientific title
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Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy
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Public title
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Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
58
Actual sample size reached:
59
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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).
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Placebo
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Not used
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Assignment
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Other
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Other design features
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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
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-23, 1397/07/01
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Ethics committee reference number
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IR.TUMS.DENTISTRY.REC.1398.043
Health conditions studied
1
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Description of health condition studied
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Oral mucositis induced by radiotherapy
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ICD-10 code
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K12.33
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ICD-10 code description
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Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
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Description
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PAIN
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Timepoint
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weeks1,2,3,4
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Method of measurement
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Numerical pain scale
2
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Description
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The rate of improvement in the severity of oral lesions
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Timepoint
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possible change of oral mucositis grade from 3 and 4 to steady levels
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Method of measurement
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WHO Grading
3
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Description
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Type of prescription
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Timepoint
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weeks 1,2,3,4
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Method of measurement
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Based on the study method
4
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Description
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period of time
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Timepoint
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Date of referral of patients in weeks 1, 2, 3 and4
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Method of measurement
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Week 1 and 2, 3, and 4 Treatments
5
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Description
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gender
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Timepoint
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Date of referral of patients
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Method of measurement
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observation
6
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Description
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Age
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Timepoint
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Date of referral of patients
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Method of measurement
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Ask the patient
Secondary outcomes
1
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Description
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Lack of the mouth wash tolerance is noted by patients and the study will be stopped if there are significant numbers of these people.
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Timepoint
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weeks 1,2,3,4
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Method of measurement
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ask the patient
Intervention groups
1
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Description
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Intervention group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by mouthwash contains of vit E , hyaluronic acid and triamcinolone
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Category
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Treatment - Drugs
2
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Description
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Control group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by triamcinolone mouthwsh
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Faculty of Education
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Grant code / Reference number
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98-01-70-38775
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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After the data collection and completion of the study, the dissertation and the article will be displayed.
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When the data will become available and for how long
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Until the completion of the data collection
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To whom data/document is available
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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.
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Under which criteria data/document could be used
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It will be acceceble in the form of a paper for use and general application.
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From where data/document is obtainable
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full professor.Dr. Farzaneh aghahoseini
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What processes are involved for a request to access data/document
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Search in the motor searches
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Comments
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All of the above will be available upon completion of the research work